Speakers:

• Scott Schliebner, Sr. VP, Clinical Development Services and Head of Rare Diseases and Orphan Drugs, TFS HealthScience
• Alison Sampson, Head of Rare Diseases and Orphan Drugs (Europe), TFS HealthScience
• Samaya, Moderator

Speakers: 

• Harold Nadin, Director of Talent Acquisition, TFS HealthScience 
• Marta Santos Espada, Associate Director of SRS, TFS HealthScience 
• Ryan Muse, Moderator, Xtalks 
  

 

Speaker 1: Ryan Muse (00:00:05): 

Well, good day to everyone joining us and welcome to today’s X Talks webinar. Today’s talk is entitled Innovative Functional Service Provider Solutions for Biopharma Growth and Transition. My name is Ryan Muse and I’ll be your Xtalks host for today. 

Today’s webinar will run for approximately 60 minutes, and this presentation includes a Q&A session with our speakers. Now the webinar is designed to be interactive, and webinars work best when you’re involved, so please feel free to submit your questions and comments for our speakers throughout the presentation using the questions chat box, and we’ll try to attend to your questions during the Q&A session. 

This chat box is located in the control panel, which is on the right hand side of your screen, and if you require any assistance along the way, you can contact me at any time by sending a message using the same chat panel. At this time, know that all participants are in listen only mode, and please note that the event will be recorded and made available for streaming on Xtalks.com. 

 

Speaker 1: Ryan Muse (00:01:03): 

At this point, I’d like to thank TFS HealthScience who developed the content for this presentation. TFS HealthScience is a full service global CRO (contract research organization) that supports biotechnology and pharmaceutical companies throughout their entire clinical development journey. In partnership with customers, they build solution-driven teams working towards a healthier future, bringing together nearly 800 plus professionals. TFS delivers tailored clinical research services in more than 40 countries with flexible clinical development and strategic resourcing solutions across key therapeutic areas. 

I’d like to introduce our speakers for today’s event. With nearly 20+ years of experience in the recruitment and operations domain, Harold Nadin is deeply passionate about assembling and guiding high-performing teams to provide tailored clinical research services. He is currently the Global Head of Talent Acquisition and UK Country Head at TFS HealthScience and Marta Santos Espada, who recently joined TFS as Associate Director for Strategic Resourcing Solutions (SRS) based in Portugal. Marta has more than 20 years of experience in clinical research having worked across the pharmaceutical industry, small CRO and large global CRO sectors. Marta has an engineering degree in biotechnology and a master’s degree in clinical investigation.

Now without further ado, I’d like to go ahead and hand the presentation over to our first speaker for today, Harold Nadin, you may begin when you’re ready. 

 

Speaker 2: Harold Nadin (00:02:31): 

Fantastic! Ryan, thank you so much for the excellent introduction. Appreciate you inviting us on today. I want to thank the Xtalks team for inviting us to this presentation, and also to the team here at TFS for their support and Marta as well. I also want to thank the people for attending today. I know in Europe, tomorrow is a bank holiday for most of the people in Spain and Portugal. I think Poland as well. So, if you are having a bank holiday tomorrow, I sincerely hope you close your laptop immediately after this webinar and call it a day. Marta, would you like to say a few words, just introduce yourself? 

 

Speaker 3: Marta Santos Espada (00:03:10): 

Hi to everybody and thank you for joining us and I hope you get as much fun listening to us as we did preparing this for you. 

 

Speaker 2: Harold Nadin (00:03:24): 

Excellent. So, let’s talk about the webinar we’re going to be running today. We are going to be reviewing a few key subjects with relations to FSP solutions within the biopharma industry. Obviously there was a brief intro there to TFS HealthScience, but I wanted to develop on it a bit further to explain how we manage our processes and the way we work here at TFS. So obviously we’re rapidly expanding CRO (contract research organization), we’re headquartered out of Sweden, we have sizable presidents in the U.S., Europe, and various other areas. Our key values are trust, quality, passion, flexibility, and sustainability. I mentioned this because these are integral to our approach to FSP work and we’ll go through this a bit further later on, but I just really want to mention that at this stage to explain how we structure our processes here at TFS. With regards to FSP, the four key things we’re going to focus on today are going to be, first of all, introduction to the challenges faced by the biopharma industry. 

 

Speaker 2: Harold Nadin (00:04:28): 

That’s a very big subject. So, we could probably do an entire presentation on that alone. We’ll start with that and then we’re going to go into some deep details about how to manage teams effectively, team structures, team management. Marty will go through that with you. She’s an expert in this field, has got some great insights. They’re going to talk to you about projects management and importance of clear consistent communication to ensure project success that honestly, that transparency is really important, that trust referring back to our values. And then my slides where I’m then going to do a slide on best practices for talent acquisition, onboarding, and retention. Again, we could do an entire presentation on that and I would love to, but we’ve only got so long, so we’ll do a quick slide on that. In addition, we’re then going to talk you through a case study which explains how we pull all this information together and shows us how we can deliver or use these lessons in practice for one of our clients. So, we’ll go through that later on. However, before we do that, I believe we have a poll. I’m just going to go through. 

 

Speaker 1: Ryan Muse (00:05:36): 

Yes, thank you so much. So appearing on everyone’s screen right now is a polling question and you can participate by selecting on any of the answers you see in front of you and then clicking submit. 

 

The question that we’re asking is, “what is your primary challenge in scaling clinical operations?” 

 

Your answer options are: 

1. Resource constraints 
2. Regulatory complexities 
3. Adaptation to market changes 
4. Technology integration 

We’ll give everyone some time to consider their answer as it best applies to yourself. And again, to the question of what is your primary challenge in scaling clinical operations? Looks like most of you have your answers in, so thank you so much for participating. 

Let’s take a look at where your votes have come down. We have ourselves here, 33% of you selecting for resource constraints and then split 22% along the rest of our answers for regulatory complexities, adaptation to market changes and technology integration. Very interesting. 

Thank you for participating, and I’ll hand things back to Harold. 

 

Speaker 2: Harold Nadin (00:06:32): 

A thank you very much. I feel like that’s the kind of question which could have had option 5, 6, 7, 8, 200- something. There could be a million different ways to explain the challenges which are facing the industry right now. I think it’s also quite interesting that they were split so well, so evenly across each of them. It’s clearly dependent on the industry or the industry, your employer, your department, your area that you work in, country, even your role type. There’s all kinds of different things which can affect your delivery. We’re going to focus first of all, the first item to actually go into that in a bit more depth and look at some of the challenges facing the industry. So first of all, if we look at the industry in 2024, despite the industry’s resilience, we’ve been navigating a series of complexities, a lot of complexities that are requesting us or require us to adapt to change, to reflect them. 

 

Speaker 2: Harold Nadin (00:07:27): 

First of all, if we look at the market dynamics, the global pharmaceutical market is valued at around 1.3 trillion, which is a lot of money in 2020, and we’re seeing an average compound growth of around 5% in the years prior to that. So we have been seeing robust growth, and this has been driven largely by things such as aging populations, prevalence of chronic diseases, and also things like emerging markets, China, India, and Brazil, which represent massive growth opportunities, huge populations, lots of opportunities to run studies. Of course with these countries, these emerging markets, there are issues with regulatory and market access challenges that require careful planning, but there was a lot of opportunity there. The issue is that a lot of big organizations, big pharma companies, it’s difficult to navigate those changes. There’s also the impact of COVID-19. So the pandemic, which seems so long ago, it’s still having a massive impact on our industry and argue with the entire global economy. 

 

Speaker 2: Harold Nadin (00:08:30): 

It distributed affected around 80% of clinical trials worldwide during its time, which led to delay suspensions, cancellations, and patient enrollment also dropped significantly by around 60% during its peak, which affected the drug development pace even further. As we all know, it takes a long, long, long time to get drug to market, and this has only hampered that even further. There’s also been the rise in virtual and decentralized trials, and this has been an interesting, I feel like it’s been a buzzword for probably a decade now, but the pandemic certainly accelerated the adoption of virtual and decentralized trials. We saw more people willing to participate in these trials as a massive increase around 72%, and also people, the virtual visits replace a lot of in-person visits, which is really encouraging, but I would argue that it hasn’t changed so great, and it’s good to see the industry starting to change and become less bureaucratic and more innovative. 

 

Speaker 2: Harold Nadin (00:09:30): 

I’d argue that it hasn’t really been the blockbuster paradigm shift, which in clinical research methodologies that we kind of thought it would become. Yet I think in time it’ll become much more adaptive and much more effective, but at this point in time, it’s not made the massive impact. We expected cost and time implications following COVID-19 have been significant as well. So the related delays and disruptions are expected to result in a net loss of around 20 billion for the biopharma industry could be actually more, and in addition to that, the price of bringing new drugs to market following the pandemic has increased by around 10 to 20% depending on the indication and the therapeutic area. And this effect, this has made a massive impact in addition to all the other time restraints that we’ve had as far as costs are concerned. Then we’ve got regulatory challenges and adaptations. 

 

Speaker 2: Harold Nadin (00:10:27): 

So, submissions have during the pandemic were significantly made more difficult. We’ve seen a massive uptake in the regulatory process and the challenges occurring, which has made things even tougher. They are starting to see a change in that. So regulatory, regulatory issues are starting to ease, but there’s a lot of backlog, which we still have to go through. But despite these challenges, I think if the industry can start to adapt to ai, start to look at new innovative ways of thinking, start to embrace things like decentralized trials and machine learning and the analytics that these tools offer, it could really help us with drug development and help us to have a much more efficient and agile drug development process overall. So, it’s been a challenging year, but I think there’s certainly light on the horizon for the industry.  

 

Speaker 3: Marta Santos Espada (00:11:26): 

Speaking of challenges and opportunities, I would like to share with you the advantages and why FSP models are an option to face these challenges and to grab these opportunities. Harold was talking about, so aligning the client’s strategy with CROs allows for the use of flexible paths by using client’s own process or the CROs proven systems, whatever works best for the project, and promotes seamless navigation through the complex project to reins with expert guidance for smooth progression towards desired goals. So, there were recent surveys that showed that around 70% of biopharma companies utilize some form of outsourcing for clinical trial services with FSP models being increasingly popular for their flexibility and cost effectiveness by aligning their own strategy with the CRO expertise. Biopharma companies utilizing FSP models experience and average on average a 20% reduction in clinical trials cycle times up to 30% faster enrollment and cost savings up to 40% in clinical trials compared to traditional outsourcing approaches. And why is this? It’s because FSP models can mitigate operational and financial risks by transferring responsibilities for specific functions such as clinical trial management or data analysis to experienced outsourcing partners, primarily due to the flexible resource allocation and pay for performance structures inherent in FSP partnerships. Sorry. Then this allows biopharma companies to scale their operations up or down quickly in response to changing project needs, market dynamics or regulatory requirements. H 

 

Speaker 2: Harold Nadin (00:13:36): 

Don’t have a poll. 

 

Speaker 3: Marta Santos Espada (00:13:38): 

Oh, we have a poll. Surprise. Yes! 

 

Speaker 1: Ryan Muse (00:13:40): 

We do. Thank you so much with our previous poll. For our audience, please select an answer you see in front of you and then click submit to participate. 

This question we’re asking you for our next poll is, “what factors are most critical when choosing an outsourcing model for your projects?” 

 

Your answer options are: 

1. Our compatibility with existing systems 
2. Expertise and reliability of these service provider cost 
3. Speed and efficiency. 

Again, the question we’re asking is what factors are most critical when choosing an outsourcing model for your projects? We’re all much faster at voting now. Thank you so much. 

Let’s take a look at your results for this poll. We have ourselves 43% for speed and efficiency, 29% of you selecting expertise and reliability, 14% both for the compatibility with existing systems as well as cost.  

So, thank you again for participating and I’ll hand things back to our speakers. 

 

Speaker 3: Marta Santos Espada (00:14:36): 

Great. 

 

Speaker 2: Harold Nadin (00:14:38): 

It’s interesting. The fact that cost was so low on there is quite surprising, and I think compatibility with existing systems will probably become more as we start to implement more AI and more automation, which we’ll go through in a bit. I think that requirement is going to increase over time. Again, there probably should have been a button which said all of the above as well. I’m sure people would’ve loved that, but it’s great insight. Sorry, Marta, over to you. 

 

Speaker 3: Marta Santos Espada (00:15:06): 

So, about strategies for peak performance. So, teams with some researchers made reveal that teams with high levels of engagement achieve on average 21% greater profitability and 17% higher productivity. So, a study by a project management institute found that poor communication leads to project failure one third of the time emphasizing the critical importance of effective communication in project success. So, these FSP model strategies of creating a strategic team setup and minimizing clinical effort by enhancing communication and positioning the FSP as a natural extension of the client allows us to ensure a bunch of important, important items. I just have a few here to share with you, but I’m sure we could be speaking about this for the entire hour, but let’s just, the ones that we found more appealing right now is first effective project management and communication. Then second well-coordinated teams that can improve operational efficiency and accelerate project timelines. 

 

Speaker 3: Marta Santos Espada (00:16:39): 

Ultimately, reducing cycle times for key deliverables such as protocol development, patient recruitment and data analysis. Another one, well-managed teams with robust quality management systems and adherence to regulatory standards that contribute to higher data quality and compliance rates in clinical trials. And this improves metrics such as protocol deviations, data accuracy, and regulatory inspection findings. 

Another item is efficient team management practices such as resource forecasting, capacity planning, performance monitoring that can lead to cost savings and reduce and resource optimization metrics such as resource utilization rates, budget adherence and cost per patient enrolled can quantify the financial impact of well-run teams on FSP delivery. 

And last but not least, well-run teams are better equipped to identify and mitigate project risks proactively and timely address issues and implement corrective actions to minimize the disruptions to FSP delivery. So, why does effective communication enhance client relationships? 92% of biopharma sponsors consider effective communication and collaboration as key factors in selecting and retaining CRO partners. 

Clear and honest communication fosters trust, transparency and stronger relationships between CROs and biopharma clients, ultimately leading to higher client satisfaction levels. Effective communication between CROs and biopharma sponsors is associated with shorter cycle times and faster study startup timelines in clinical trials, timely updates, progress reports and proactive issue resolution contribute to improved project efficiency and delivery. 

 

Speaker 3: Marta Santos Espada (00:18:44): 

78% of biopharma sponsors rate effective communication of project risks and issues as critical for successful project delivery. Transparent communication allows for early identification and mitigation of project risks, reducing the likelihood of delays, budget overruns, and quality issues. Clear and honest communication helps align the expectations and deliverables between CROs and biopharma sponsors, ensuring the projects objectives, timelines and resource requirements are clearly defined and understood by all stakeholders. 

Misalignment of expectations is a common cause for project delays and client dissatisfaction in outsourcing relationships. So effective communication enables CROs and biopharma sponsors to navigate changes, unexpected challenges and evolving project requirements with agility and resilience. Open communication channels and regular stakeholder meetings facilitate collaborative problem solving and decision making in response to changing project dynamics. So, for all this, I think that one of the biggest advantages of an FSP model is the building of bridges and communication channels between the CRO and the client leveraging from all parties knowledge and expertise. 

 

Speaker 2: Harold Nadin (00:20:13): 

Thank you, Marta. Next up, invitation, recruitment, retention and getting a bit of echo. I think it stops. So willing, war for talent, strategies for acquisition, talent acquisition and retention. So, despite all the doom and gloom we see as far as economic projections and the media, the biopharma industry is projected to create 4 million new jobs between now and 2030, which underscores the growing demand for talent within the sector. 

I was actually quite surprised when I learned that it’s a huge number of new positions that are going to be created. I think it’s more important now than ever for organizations to have a much more strategic approach to talent acquisition to attraction, and to really allocating what it is they need from the skill sets from their professionals. I think gone are the days when you could just say, okay, we’re going to replace the people that leave and we’re going to hire when we have new business requirements that’s gone. 

 

Speaker 2: Harold Nadin (00:21:18): 

Businesses need to have a much more structured approach to recruitment and a long-term plan, the strategy for how they deliver. Now, AI is a huge, huge discussion point within I think most industries, but recruitment in particular. I think new technologies can certainly help improve recruitment processes and increase the number of candidates we have coming through talent pools, but I think it’s going to have a massive impact in recruitment in particular, particularly when it comes to candidate engagement. 

Rather than seeing AI as a new workforce for recruitment, I don’t see myself or my team being replaced by bots anytime soon or avatars or anything like that. I see it much more as a way for us to improve or increase the amount of candidate engagement we can do and to improve the quality of the candidate engagement and the candidate journey. 

 

Speaker 2: Harold Nadin (00:22:09): 

So, within this, in particular, but if I speak to my recruiters within my team, or in fact generally within the industry, if I say to them, okay, what could I do to make your lives easier? How could we improve your productivity or improve the amount of outreach that you do or the amount of hires, the same response will always become, and that is, I do too much admin. I want you to take away the admin. I don’t have time to set up my interviews or do X, Y, Z or whatever else. 

Do reporting, and I think that’s where AI can really impact recruitment, particularly within this industry. If we can take away some of the more administrative tasks, it gives a lot more time for the team to focus on what we used to do within the old days of recruitment. Focus more on having a talent portal, having groups of people that you connect with very, very regularly, even if you don’t necessarily have a job for them right now. 

 

Speaker 2: Harold Nadin (00:23:02): 

I think that approach to recruitment’s really gone back in the day when I started in recruitment. They would add a little black book, put people’s names in, and I would write ’em all down in pen. I’d pick up the phone and I would phone them. That’s gone now thanks to there’s lots of automation and these kinds of things, great systems, but I think if we can enable our guys to have more time to have those kind of old school conversations and those old school communities, it’s going to have a really positive effect on recruitment and candidate experience. And of course the hiring manager experience as well. 

As I’m sure a few of you are, it’s fascinating when I think about it. My first recruitment job back in the day, believe it or not, we were faxing CVS to our clients and we’d received CVS by fax and by letter. 20 odd years later we now, there’s avatars speaking to candidates and all kinds of different things that we’re doing. So, it’s crazy to see the change that’s happened in time. 

 

Speaker 2: Harold Nadin (00:24:00): 

I’ve been particularly interested in this from my perspective as the head of recruitment for TFS back in Q1, beginning of Q1, we enabled AI into a lot of our processes within the organization. Not massive change, but small things here and there, specifically interview scheduling, generating job descriptions and job efforts. 

We used that AI for that. We also used AI to help us create new interview processes. We could target specific behaviors and specific competencies. These kind of things would’ve taken hours and hours of work prior to us implementing this, but now we can do the press of a button, which is fantastic, and arguably often you could say that they do a better job than some of the recruiters would’ve done before. 

Sometimes need some changing, some honing. But overall, it’s been really, really, really, really positive despite the fact that only a little bit of time has passed, we’ve seen a fairly dramatic reduction in time to hire, and we’ve seen more significantly higher number of applications coming through as a result of new systems and processes we’ve got coming in. 

 

Speaker 2: Harold Nadin (00:25:02): 

So, the early signs of the data and the information which is coming through is really, really, really positive. I’m fascinated to see what it looks like at the end of the year once we’ve got more data and we’ve got a bigger, bigger norm group for us to look at, but it’s been really good. Another good thing with AI, the analytics, which comes off the back a bit, is fantastic and we’ve got some great new tools which allow us to see when people drop off, why they’ve dropped off, how many clicks, all these kinds of things which can report back to us and make recommendations. 

These are the kinds of things which are very, very valuable to me as a talent acquisition manager, but also really, really valuable for the team and also our business leaders too. So, I think AI is going to have a really, really positive impact on recruitment. It’s going to save us a lot of time and a lot of admin, which recruiters notoriously hate. 

 

Speaker 2: Harold Nadin (00:25:53): 

We need to make sure, of course, that we retain the personal touch. I think it’d be very, very easy to just have a very, very high volume, reach out messages, emails, and really forget the personal approach, which is integral when you’re speaking to a candidate. Building those authentic relationships is really, really important. If you don’t build those relationships, then you will, well, you won’t get these people to come and work for you. If I think about when I speak to my recruiters, especially the guys that are earlier in their career about what are the most important things you should be thinking about when you speaking to a candidate, they’re obvious ones are experience, maybe salary, expectations, notice period, that makes sense of course. But the number one and most important question is the candidate’s motivations. Why do they want this job and what are they looking for you as an employer? 

 

Speaker 2: Harold Nadin (00:26:47): 

These two questions are so important, A, because you can be frank and say, okay, yeah, of course we can offer you what you’re looking for, great news, but you can really help to build their motivations into the negotiation at the end. So when you make the offer, you say to them, not only we going to offer you your dream job and a fantastic salary, we’re also going to offer you all those softer things that you mentioned right at the beginning of the process, which helps to really help to seal the deal when you’re closing the offer. 

So again, I think AI will help to enable these conversations, but I think we’re always going to require the personal touch. It’s going to be particularly important, especially for these FSP projects where you need people who really bought into the client, really bought into the organization. It’s going to be super important. 

 

Speaker 2: Harold Nadin (00:27:31): 

Good recruiters engage hearts and minds when you’re hiring candidates. If you think about if you may have been looking at new jobs yourself, or you may have moved jobs recently, you must really think about the fact that changing jobs is very stressful. You don’t know if you’re going to like your new job. You don’t know if you’re going to like your new boss. Maybe you miss your old job, maybe the systems aren’t as good. Maybe you’re overwhelmed, you’re overworked, you’re underworked. Underworked is a surprising issue, believe it or not, a lot of people feel like they don’t have enough to do or they feel like a bit of a spare part and that comes up more often than you might think. So, there was a lot of stress doing that and make change in those jobs. So, building that rapport and building that trust is again, very, very important. 

 

Speaker 2: Harold Nadin (00:28:16): 

Referring back to that personal touch, it’s extremely important you respect that candidates when they’re going through the process. I’m referring to recruiters here, but I’m also talking about hiring teams. You as a hiring manager, and I’m sure there are a few of you on the phone today who have hired people who are part of hiring teams, it’s extremely important you treat your candidates with respect. I’m sorry to turn this into a lecture, but make sure you are selling. 

Make sure you are assessing the motivations. Get to know them, build that rapport with them, even if they aren’t right for your job right now, they may be right for a job six months down the line, or they may be right for another job within another team within your organization. Always be selling, always be positive. You need to be thinking about the mindset of that individual as they’re sitting down to interview. 

 

Speaker 2: Harold Nadin (00:29:03): 

I personally hate interviews. I’m sure a lot of you guys too, so it’s important you make that process as simple and enjoyable and productive as possible. Onboarding processes, onboarding I think is more important than ever now, and it’s critical for setting new hires up for success. You need to integrate them into your culture. You need to integrate them into your system, your technology, some of the things I mentioned before, the workload, the demand, the management style, all these kinds of things. 

So, it’s really, really important. You’ve got a great onboarding process set up. It’s also important that you have people that own those processes, not the delivery of those processes. It may be that HR does this part of the process or it does this part of the process, but you need someone to own the overall process to make sure that gaps aren’t missed or things fall through cracks. 

 

Speaker 2: Harold Nadin (00:29:52): 

Onboarding what happens if this goes wrong? The negatives of onboarding got a quick snap for you. Society for Human Resource Management said that the turnover rate for the life sciences industry is 17% higher than other industries. So we have a high turnover rate within life sciences across all other industries. That includes banking, retail, FMCG Tech, we are significantly higher, which is quite surprising to hear. But in addition, they also noted that our new employees are 69% more likely to leave in the first six months. Now, that is a very, very concerning stat for me as a recruitment manager. I don’t want to have to be recruiting for people every six months for people that have left organizations, but it also goes to show that there is a gap there within our industry where people are not being onboarded in the right way or to be honest with you, not being hired in the right way. 

 

Speaker 2: Harold Nadin (00:30:47): 

Maybe the recruiters are overselling the position or the hiring managers aren’t selling it in the right way or they’re underestimating what is required for the role. It’s super, super important. You get the onboarding right. Cost of replacing staff can vary wildly depending on the role you’re in, but it can be anywhere from 20%. It’s usually around the average, but I have seen numbers go up as high as 200%. If you think about costs, training, time spent, recruited costs, everything else, lost client revenue, all these kind of things, especially with an FSP start to mount up, it’s very, very important. You get your onboarding right. There are a number of ways that you can ensure of a good onboarding. First of all, a good orientation program, a good standardized program, which is, as I said, managed by a process manager and has clear people who are responsible for different parts. 

 

Speaker 2: Harold Nadin (00:31:37): 

This may sound very obvious, but even things such as who sends the it? What are the timeframes for it? By it I mean laptop, all that kind of stuff. Who went to the, are the goals set up? How are the benefits communicated? All of these different things are, there’s so many different things you have to tick off, and it’s really important that that is owned and managed very, very well. 

Again, particularly with these FSP deals or these FSP projects because you need to make sure you’re bringing people in and onboarding quickly and make ’em successful as quickly as possible. Another good way of ensuring great onboarding is to have a mentor and or a buddy, again, not just having some piecemeal approach. You need to make sure that you define exactly what the responsibilities of the buddy are and exactly what the responsibilities of the mentor are. 

 

Speaker 2: Harold Nadin (00:32:20): 

Now, this will vary depending on who you are, your organization, whatever it may be. But generally the buddy tends to be your shoulders to cry on type individual, the person who asks the silly questions and I still have plenty. And then your mentor tends to be a person you need for that technical experience and the way that you interact with those two people can be completely different and each organization will manage it differently. 

But if you don’t have it defined, get it defined because it will just be a waste of everyone’s time. Structured training development, of course, you need to make sure that you structure your training and development, ensure these people train those gaps and fill in those areas where they need improvement. Have seen companies go as far as testing people before they join, whether it be for psychometric tests or verbal numerical reasoning or even skills testing so they can see where the gaps lie before the individual starts. 

 

Speaker 2: Harold Nadin (00:33:08): 

So when they join on day one, they’ve got a nice structured training program would be amazing. Those kinds of things are fantastic ways to work. Obviously it’s a lot of administration and cost, but you can really go to the extreme and be exceptional like that. But at the very end, ever end, you’ve got people who don’t have any training, no onboarding, nowhere to go for issues or queries. You need to make sure you’ve got good structured training and development really as well. When I think about development, you need to make sure there are career plans as well in place for individual. If you’re joining an organization, you’re not joining that organization to stay in the same role for the next 20 years. You’re joining that organization with the idea that you’re going to step up into the next level or the next level potentially into different teams, different departments, and it’s important you have those career pathways mapped out so that people can see those options and see that development. This as well will massively produce retention. One of the main reasons why people leave, particularly in the first two, six months to two years is because they don’t see any career development within the organization. And that’s a travesty when you talk about when we talked earlier on about the amount of money it costs to replace these people, we shouldn’t be losing anyone in the first year. Obviously some turnover, staff turnover is good, but not in the first 12 months. We don’t want that. 

 

Speaker 2: Harold Nadin (00:34:23): 

I wrote another good way of onboarding people is regular check-ins and feedback. That might seem really obvious, but you’ll be surprised how few people actually have regular check-ins and feedback with the hiring manager. And when I’ve looked at it, a previous employer of mine when I’ve looked at the research, tends to get worse as you become more senior. There was a senior person I met at a previous CRO and we were talking about his plans for his team, what are your plans for the year? What do you want your team to look like? Where do we need to focus the hiring headcount, planning, that kind of stuff. And I said, have you connected with your boss? And he said, no, I haven’t spoken to her for a year. I said, what do you mean you haven’t spoken for a year? And he hadn’t had a one-to-one with his boss for a year. And that for me was again, very alarming. And you think the more senior you get, the more experienced you get. This would be an obvious thing you’d do, but it’s surprising how little that happens. So it’s important that you do that if you’re a manager and certainly something which we pride ourselves on the TFS, it’s something that I pride myself on. Speaking to my team very regularly is critical because you will lose engagement and you’ll lose focus and they will lose sight of their goals and unfortunately they will fail. 

 

Speaker 2: Harold Nadin (00:35:37): 

Onboarding great way to onboard people effectively is to get ’em involved in social interactions and activities. Got a lot more challenging nowadays with a lot of people working remotely, particularly in our industry. I know for instance, myself, I work, I live in Leeds in the uk. I’ve got Rob who’s over in the US and I’ve got Nash, who’s down in Beck Cansfield near London. We’ve got three guys in Spain, a few in Sweden. It’s very difficult for us to all get together and have a drink or go bowling or whatever it is that you want to do for social activities. But if you can’t meet in person, it’s important. You meet virtually, team meetings, meetups, all these kinds of things, celebrate birthdays, successes, these things. Try and make it social. Try and engage people as much as you can. If you are lucky enough to have people in an office nearby to you, take the time to meet up. And I know especially for I think at the FSP team down in Spain and in Portugal, and we’re going to talk through the case study example in a second. They’re really good at that. They’re really good at pulling teams together and meeting up, and I think that’s another reason why the engagement is so strong down there. 

 

Speaker 2: Harold Nadin (00:36:45): 

I could go on about onboarding, but I’m going to move on to retention now. Retention in many respects is quite similar to onboarding. Retention just tends to be a development onboarding through to the next stages. I’m going to give you some more stats now. So organizations with high engagement levels, which goes hand in hand with retention, are 21% more profitable and experience 41% lower absentees to 41% of people not turning up for work. Again, those numbers speak for themselves, but I think it’s important that you do. Once you’ve got people on onboard and ready to go, it’s so important you keep them engaged. And again, I’ll go through these examples in a second. Some of them are quite similar to the onboarding, but it’s very, very important and do, it’s crucial to ensure that the standards don’t drop your KPIs, don’t drop your metrics, don’t drop your delivery doesn’t drop ways that you can manage retention, improve retention, career development opportunities. I talked about career mapping earlier on, knowing where you’re going to be going next, recognition and rewards programs, recognition comes in many ways. These things can be bonuses, these things can be salary increases, whatever it’s may want to do it, and often that’s what people think of when they think of recognition and reward. But often some people just want to be celebrated. They just want to a high five or a mention from the CE or mention from their boss or someone else. 

 

Speaker 2: Harold Nadin (00:38:10): 

These kind of things may have a massive impact on how someone feels. Money is great and I’d all love it. We’d all have a bit more money. I know that for sure. But often just having someone mention the fact you’ve done an excellent job and the time you put in has been recognized can have a real, real impact on you as a person, more so the mint money and really helps you to feel part of the community work-life balance initiatives are great. I, it’s different depending on project demands and client demands, and it also varies depending on your employer. You might have one or two projects, you might have 10 projects working on depending on which organization you’re with, but it’s important that you take time to do that. And these can be social activities, but it could also be, I know a lot of organizations nowadays have days out where they’ll do charity work or charity events. 

 

Speaker 2: Harold Nadin (00:38:57): 

These kinds of things are really good, but also also flexible work. I know some companies implement core hours, but outside of those times, people can start and finish when they need, and it varies depending on location and again, your project that you’re working on. But those flexible work life initiatives can be really good. These also include things like paternity pay, extended paternity pay, extended maternity pay, paid leave, unpaid leave, all these kind of things. It’d be really useful to keep people retained and keep them in the organization. Policies on these things are also very important. It’s, it’s good to have all clear so that everyone’s on the same page as to how these work. I mentioned compensation earlier on, but again, good compensation benefits is important. Salary ranges, obviously we’ve seen a lot of inflation over the past few years and we have seen a stock increase in salary ranges. 

 

Speaker 2: Harold Nadin (00:39:44): 

Again, we probably talk a lot about that, but it’s also the benefits as well. A good set of competitive benefits can be the difference between someone joining you and someone joining a competitor. I know this is more of a HR thing or recruitment thing, but it’s definitely set something to speak to your HR team about. If you are in a senior role because there’s slight improvement, the benefits can have a massive impact. Opening communication feedback is really important as well for attention. You want to be able to speak to your bosses, you want to be able to speak to your team without judgment. I think it’s super important that you foster that kind of environment. I know I definitely do within my team, I have to have a lot of difficult conversations with people, of course, and they’re very honest with me and I won’t say any names. 

 

Speaker 2: Harold Nadin (00:40:25): 

They know who they are, but to be honest, for me, I love it because it means I know exactly what the issues are and we can make those changes quickly. So I encourage you and any managers here to take that approach. And then finally got two final points. Employee engagement surveys, the surveys, we send them out I think now twice a year, and most companies are running them nowadays. I think a lot of organizations or people who run those surveys see them as tick box exercise more than anything else, but they should not be underestimated. The information you gather from them is frank, honest, anonymized feedback from your team as to exactly how you’re running the company and how you could improve. Don’t waste those opportunities, use that information to make changes. And then finally, promotion of diversity and inclusion. Obviously this takes many forms, but that diversity of thought, diversity of background can have such a great impact on your organization. Obviously the more the team, the more effective the team can be. So it’s very, very important you factor that into your retention plan. I think if you implement these improvements, you will see an increasing retention. Again, we could go into a lot more depth, but high level, that’s what you should be thinking about. 

 

Speaker 2: Harold Nadin (00:41:38): 

Now, we’re now going to talk, I mentioned before, we’re going to talk about case study that’s going to encapsulate all of these things that we’ve discussed, and I want to give you a real life example and specifically our recent Portugal project. Before I dive in, I must emphasize that whilst I’m presenting this project overview, I can take only the smallest amount of credit for the work that has been delivered narrat rating more than anything else. The real thanks and the real delivery itself really is owed to the S-R-S-F-S-P team. No sole, my recruitment team, Jayla, Lord Marta, of course, the finance team, Marta Halladay, everyone, all these people that work together to pull this project and together and make it a success. I can list, I’ll give a long list of names, but I word, but I think we couldn’t have done it unless we had pulled together as a team. I think it’s important to mention that not just because they deserve the thanks, but because we wouldn’t have succeeded if it wasn’t for the support of these individuals. So thank you all to your contributions. You know who you are. 

 

Speaker 2: Harold Nadin (00:42:46): 

So high level, back in 2022, a client of ours got in touch as they wanted to review their current FSP provider in Portugal. They’ve been in place for several years, but there were some key issues which had come about. The three top ones workers will structure. So the client themselves, they wanted to merge Spain and Portugal into one holistic Iberia region for a multitude of reasons, but they needed a provider that could adapt in both regions of both markets and grow and scale up. They’re also concerned about quality. Portugal is notoriously difficult from a quality and project management delivery perspective. I’m sure Marta can agree, but I think that the project delivery had started to deteriorate, slightly started to plateau, and again, you put it down to the Portuguese difficulty of regulatory concerns, everything else, but there was concerns that the provider would start to drop the ball slightly. 

 

Speaker 2: Harold Nadin (00:43:42): 

And then finally, long term, the client wanted to increase the volume, the number of studies taking place in Iberia overall. But in order to do this, they need to make sure I had an FSP partner with a scalable agile, could deliver, trusted, let’s going back to our values again and had the integrity to be honest and a trusted partner with them. So that was the reason why this came about. And then in step TFS, so we’ve been working with the sponsor in Spain for several years, and we’ve been able to establish a relationship for quality speed, adaptability, and we’ve done exceptional amount of FSP delivery in Spain. We’ve got a great team in Spain and they’ve been in place for several years. We’ve got good quality, good processes, so we had a great reputation. They made us aware of this situation and we went to tender. 

 

Speaker 2: Harold Nadin (00:44:37): 

But whilst we had that great reputation in Spain and great processes, an established team, we faced a big challenge. And that was that we had no presence in Portugal. We didn’t have an entity, a bank account, an office contracts, legal representation, staff, anything. Big, big, big hurdle. But instead of hesitating, we decided this was a good opportunity for us to grow our business, good opportunity to expand the relationship with this sponsor. We’d already done a fantastic relationship with them and just building more and more onto it. But we also knew that the integrity and honesty were going to be vital for the success, both for the projects itself, but also for the client relationship. If we dropped the ball, then we risked losing relationship overall. So this wasn’t just a tender to open up a new market. This was a tender that could potentially jeopardize the entire relationship with this client. 

 

Speaker 2: Harold Nadin (00:45:35): 

We wanted to throw our hat into the ring, but we had to make sure that we knew that we could make this happen. It was very, very important. We did that. So before we even submitted the tender, we then started to pull together the team. So we pulled the guys from the SRS, Spain team, PLAR sole, the rest of you, again, you know who you are. They pulled together a team of great people who knew the processes, they understood the regulatory issues, they understood what quality and what could look like specifically for that sponsor. 

So they were the core team. We then pulled together the hiring team. So I had two members of my team who had experienced hiring for that vendor and also both spoke Portuguese. So I reallocated them from one project to another. Obviously very valuable, but I make a point of hiring people that speak as many languages as possible for just this eventuality, and I knew that they understood the client demand. 

 

Speaker 2: Harold Nadin (00:46:34): 

I also assigned a project manager from my team, a guy called Sam, who is a much better project manager than I am. And I knew that he would be able to maintain good deadlines, good standards, and make sure the energy was going to remain high for this critical need. We also needed to identify the functional back-office partners so we can have a hiring team, we can have a team of people to manage them, but if we can’t build an entity or a bank account or anything like that, then there’s no point. 

So, there was some crucial support from our legal team, facilities team, HR, comp. These were the team that would help us understand how long it would take to set up these key things, how long it would take to open an office, contracts, these kind of things. This is why I mentioned at the start, the importance of bringing together the team. 

 

Speaker 2: Harold Nadin (00:47:21): 

We were all sat there. We all had one big problem we had to solve, and we had to be honest with each other. We didn’t have much time to solve it. We recognized be huge amount of work, but we’d identified the deliverables and the key challenges, which made the initial project implementation. From our perspective, our end very, very easy. Well, not easy, clear, we went to tender. We were very honest with the client. We flagged our advantages as a provider, and I think they were obvious, but we also, and also the track record over the board in Spain, but we were also very honest about our limitations, our challenges, and we explained how we would work around them, how long it would take to ramp up. And I think actually before I mentioned that, but also in the background, we were also begin to look at the quality and compliance and regulatory issues that we were going to face by adapting and growing into Spain. Obviously this is very, very important for us to do. Again, top of mind from a values perspective. 

 

Speaker 2: Harold Nadin (00:48:22): 

Yeah, it was very, very important that we did that. In addition, we also started to pipeline talent in Portugal as well. So even though we hadn’t actually signed anything at this stage, the team began to build pipelines of talent, began to have conversations, high level conversations with candidates, which was very, very useful. And that really helped us, again, with the honesty in mind, with the integrity, with the background, what we were doing. And the client was very, very appreciative. And we then went on to sign terms back in August. Our track record was a real big benefit, but I also think the honesty, which we were very honest with ’em upfront, this is going to be the challenges. This is how we’re going to fix them. I think that was really important for us winning the tender. We were up against very, very big name CROs that they could have gone with rather than us. 

 

Speaker 2: Harold Nadin (00:49:09): 

There were also other midsize and smaller CROs that were up for the Tinder, but they went with us because of the fact that we were offering something different. We were agile, we were scalable, we were proof of that. So, in September 2022, TFS embarked on this transformative FSP project in Portugal, and it was a big, big thing for us. It is a milestone for the organization. And over the following months, we’ve then started to work to bring it to fruition. Everyone, legal, finance, HR, TA (talent acquisition), and the business we’re able to set up the entity. We would then set up employment benefits and contracts in our bank account. We spent a lot of time particularly looking at comp and bend because it’s important that we ensured our compensation was attractive compared to our competitors in the market. We also found an office, which was great. It’s a really, really nice facility, and I think the guys really, really liked it, which is great. 

 

Speaker 2: Harold Nadin (00:50:07): 

We then began to go to markets. We started to look at, we would use all the recruitment channels, we could look at direct outreach, LinkedIn referrals. We went straight out to market and then took it up a notch as far as how we were attracting the client candidates. But in addition to that, we made sure that we had a clear strategy from an EVP perspective because we weren’t known in Portugal. We were an unknown quantity. Why would you go and work for this random company that’s turned up? So, it’s important that we had that message clear, and that was that we were growing, we had grand ambitions. We wanted to bring a new level of quality, a new level of process to Portugal, had a great big project. We have a great big client we want to work on, and the way we treat our employees and engagement with employees is fantastic, and we don’t overwork them. 

 

Speaker 2: Harold Nadin (00:50:56): 

We’re very honest with our approach. It’s a team mentality rather than individual KPI driven mentality. This really, really helped us to engage with candidates and got us out to the market very easily. So, at the beginning, things were looking very good. We knew that we’d have probably four or five months to get everything going. I think getting into Q1 was the initial go live date, but then unexpectedly, the current provider decided that they wanted to withdraw. And this happened in November. So, in November they said, we’re going to withdraw from this project, and you’ll need to take on ownership of the project at the end of December. So, we’ve now had the project cut down by three months. Now, this was a huge problem for us. Not only are we having to build a new market, open up everything that we need to do, all of the other things I mentioned about hire, all the staff, it was a large team that needed to be hired in a short time. We then had to do it in three months less time, which was a shock. 

 

Speaker 2: Harold Nadin (00:52:04): 

But I understand why the current provider did it. They were not satisfied with the fact that they lost their clients. So, partly it was kind of understanding and it was disappointing to hear. But the good thing is, is when we spoke with the sponsor, said to them, look, this is a problem. We’re going to adapt to it. And the sponsor was gracious, which was fantastic, but they also said, we’ve got patients and we’ve got studies that need to be managed, so we respect that this is going to be really hard work, but you’ve got to pull the cat off the bag to coin an English phrase. So this, we had to completely adapt everything and change all our plans. We had two months to take on the study. We were at a huge challenge on our hands. But with these kinds of things, it always happens with projects. 

 

Speaker 2: Harold Nadin (00:52:48): 

There’s always shortfalls, there’s always issues, deadlines change, and you have to adapt to the client needs. So team met remain resilient. We were already meeting with the client I think at this point once a week where we had meetings with the recruitment team, close collaboration meetings, data updates, make sure we’re staying on track. I think this then became biweekly. And then we were also meeting with the current provider as well to ensure that all the data was transferred effectively. And it was really important for us to help us adapt things. And the client was very much appreciative of this. 

 

Speaker 2: Harold Nadin (00:53:24): 

We started to contact the employees from the current provider as well to try and attract them over to come and reach with us. We wanted to make sure that the interview process was extremely thorough because we did have concerns around quality as well. So, we did contact some of them, but unfortunately, for the existing client, there were a lot of counteroffers, and there was also a promise of new projects. Unfortunately, a lot of them didn’t materialize for them, but this really slowed down the hiring even further. We knew that if we were going to be successful, we were going to need to broaden our search. We started to have some fairly honest conversations with them [the client]. One of the things we realized is that hospital study coordinators were a great place to hire potential junior CRAs (clinical research associates) for a client. And we’d seen success of this elsewhere o other projects, both on the full-service side and the FSP side. 

 

Speaker 2: Harold Nadin (00:54:13): 

So, we took this idea to them and said, look, we should be hiring, okay, there’ll be gaps in skillset and gaps in knowledge, but we’ve got some great people here. Great attitude. And really if you can hire for attitude and you can fill all those training gaps, you’ve got some great potential here. Some great staff had this conversation with the client. They’re appreciative, and while they didn’t make up a huge amount of the hiring, it helped us to plug a few of those little gaps. The little gaps in hiring. You have left one role here. Long roll over here was really good and really helped us be successful. Now, I’ve been talking a lot about recruitment. I’m conscious of time and I’m going to talk about the standards, the work the guys were doing. So the delivery itself, again, one of the reasons we won the relationship was the great success we’d had in Spain. 

 

Speaker 2: Harold Nadin (00:54:59): 

And when we went in, we spotted a lot of issues with the current service levels. I think some of the KPIs weren’t great. Trackers study documentation, there’s a lot of concerns. We had regulatory issues and we agreed the sponsor and the client that we would make significant changes. We met with the client very regularly to establish these, and the current provider was actually fairly supportive and helping us transfer everything over. As I mentioned before, I think the way we kept these standards high was, first of all was we set new KPIs and metrics of the client replicating what we were doing in Spain. We knew that was a good level, great service. Let’s move it over us and apply as much as we can. Great onboarding. It was really important. We wanted to make sure that they were onboarding in the right way. The EVP was good. 

 

Speaker 2: Harold Nadin (00:55:51): 

They had great client engagement. We had people from Spain who were able to teach them what quality looked like, what could look like, but also we made sure that it was communicated simply and effectively because we didn’t want to overwhelm them. We didn’t want to put the urgency onto these poor guys who just joined us as an organization. They don’t need to know there’s all this urgency happening. And again, that buddy and mentor relationship between the two regions was really important. We created action plans for the individuals, as I mentioned, but we also created action plans for the team, and I think that was what really helped to mentor foster the team environment for the guys there. The success is built based on the team’s results, the team’s KPIs, the team’s goals. And this team mentality has meant that they have fostered a really great relationship. 

 

Speaker 2: Harold Nadin (00:56:41): 

And I think I want to talk about this a bit later, but the employee engagement surveys in Portugal have been fantastic. Every single time we do one, they’ve been really, really positive, great management. Of course we’ve got Marta down there as well who definitely has an impact. But the fact that they focus on team mentality is great. And I think in addition to that, whilst there are some things that come from the more senior management improvements that need be made, a lot of the improvements and processes and honestly improvements to improve KPIs and metrics is actually done by the guys in Portugal. They come up, we say to them, how do you think we can improve that particular metric or that particular KPI that timeline, and they do it themselves and they come up with the ideas. And again, it really fosters that team mentality and it helps ’em to feel like they’re part of that client, part of the FSP client. 

 

Speaker 2: Harold Nadin (00:57:28): 

And I think that seamless integration between the two is so important with these kind of projects that empowerment, it’s really good for helping build communities conscious of time. I want to maybe go through it. So, the December ‘go live’ came, Spanish support during this period was critical. We could not have been able to deliver without them. There was a lot of guys in Spain that were supporting with a lot of work in Portugal during this period when in December ‘go live’ came. We had hired quite a few people, to be honest with you, despite the short timeframes, but there was a lot of support from them. We got compensated with overtime of course, but in addition, we tied a lot of the stuff into their goals and KPIs and development plans. So, it felt like rather than it feeling like us helping them, it was a regional goal. 

 

Speaker 2: Harold Nadin (00:58:12): 

It was supporting the whole team for this particular sponsor. So, it didn’t really feel like it was a labor, it was more of a we need to work together to get this done. By the end of February, almost all of the staff were onboarding. In fact, pretty much all of the onboarded. By the end of February, we allocated most of the resource from Spain to pick up the slack, but then we were able to offboard them later that month and had very, very, despite the fact change in the timeline, it had very, very, I think had any impact actually, in fact on the quality or in compliance issues or anything like that from a delivery perspective. So we were really happy one year on or just over one year on. Now things have got even better for us, which is fantastic. So again, Portugal is a tough market. 

 

Speaker 2: Harold Nadin (00:58:59): 

As I mentioned before, to manage from a regulatory perspective, startup perspective, and this can be quite discouraging for sponsors, but we’ve made such a good improvement to quality and delivery that the sponsor is now putting more projects and needs more resource in al, which is fantastic. And for them from their perspective, they really want to raise the credibility of the Iberia region and the significance of the Iberia region within their organization as well. So that quality is so, so important. So we’ve been able to replicate that and help them as well to raise their internal brand within their organization, which is a really good to hear onboarding and engagement remains consistent. We’re not being complacent though, so for instance, we constantly need to change things and make sure things getting better. So from an HR perspective, I know we reviewed benefits recently to make sure that they were still competitive. 

 

Speaker 2: Harold Nadin (00:59:52): 

We also looked at, we’ve also very, very recently decided to take another look at our career pathways for the clinical operations teams, CRA, CTAs, et cetera, to make sure that they are competitive and are engaging and we’re going to help people to see a path for themselves, so not being complacent, making sure we continue to improve the experience for these guys. Our leaders of course, remain humble. They listen to the guys in Portugal, they to TA as well, which I’m very, very happy about. Listen to HR and legal, and then they listen to the team. They’re a great team that we work with down in South Europe and they help us to learn and grow and fix things. And then we’ve built such a strong relationship now they’re built on trust, built on honesty, scalable as well. So important for FSP work, scalable agile approach. We’ve shown that we can do it and it’s only going to hold us in good stead in the future for this client. I could go on, but I’m conscious of time. Marta, have I missed anything? 

 

Speaker 3: Marta Santos Espada (01:00:54): 

I can’t get tired of this story. Really. Really, every time I think of this story, it makes me believe this so much. Because today we are a team of 27 people in this FSP model and it’s so great to see how everything works or how everything fit together so perfectly with IT was not just now Portugal start working. No, everybody contributed. Everybody helped. Different countries working together to pull this off. It’s really, really, really an inspiring story. I could stay here two hours listening to you talking about this. Really. That’s true. 

 

Speaker 2: Harold Nadin (01:01:49): 

I mean, everyone wants to be part of something, right? Everyone wants to grow something professionally or personally, but I think this was, like I said, my involvement with this project was small, very small compared to some of the other people. But even my small part, it was great and I’m really pleased with it. And it’s kind of set benchmark for what we want these kind of projects like in the future for our FSP clients. So yeah, there you go. I think that’s the final point on that. 

 

Speaker 1: Ryan Muse (01:02:20): 

All right, well thank you very much for this very insightful presentation. I’d like to invite our audience to continue to send some questions and comments right now using the questions window as we move into our Q&A portion for our webinar today. I’ve got a few questions from the audience, so let’s get started with what we’ve already received so far. 

The first question that I have here would like to know is, “if you can give an example of how FSP models have specifically addressed and overcome regulatory complexities in a recent project.” 

 

Speaker 3: Marta Santos Espada (01:02:52): 

Yeah, I can take this one for sure. I can share the example following in the same sequence of this Portugal case study that Harold was presenting, it’s a team, a new team, a recent team, and we started working with this client and for regulatory actions, we started working. At first we started working with our colleagues in Spain that were our mentors in pretty much everything about TFS procedures and how things worked and everything. And they already knew the sponsor, so they helped us a lot and mentored us. 

For this specific FSP model, we work together with the client, with the sponsor. So for regulatory submissions and procedures, for example, our clients handles the regulatory authority part of submissions and TFS handles the ethics and country specific part of the submissions. And this is particularly, it’s very, very, very helpful for the new EU CTR process, for example, because it works very smoothly and very stress-free. And we haven’t had anything going bad so far in this year end. Something we’ve been working and everything’s been working really, really well. Again, due to constant communication, constant work team using subject matter experts, every time somebody anybody needs, nobody’s alone ever. So, I think it’s the big tip here is nobody needs to work alone. Nobody needs to invent the wheel. 

 

Speaker 1: Ryan Muse (01:04:58): 

Very good. Alright, thank you so much for that answer. Another question I have here for you would like to know, “what are some of the most common pitfalls that you think companies face when transitioning from a traditional FSO model to an FSP model? And do you have any tips on how they can be avoided?” 

 

Speaker 2: Harold Nadin (01:05:15): 

I think that’s a question for you, Marta. 

 

Speaker 3: Marta Santos Espada (01:05:16): 

Oh yeah, I can manage it. I just need to think of it. It’s not the easiest question of all, but let me see. Some pitfalls that come to my mind for this type of transition would be the selection process of the CRO itself or the FSP model because the sponsor might have trust issues in the new hires. We don’t know who people are. Who are they, how do we trust that they’re going to be the ones that we want to, okay, so in our case, for example, in TFS, we gave our clients the opportunity to perform a less round of interviews to know the people we were choosing to work with them so that they would see if these people would have their profiles that they like, that they consider relevant for their values for their company. 

 

Speaker 3: Marta Santos Espada (01:06:28): 

Another pitfall would be invoicing, for example, how do we invoice the services? How does the CRO invoice the services to the client? For example, you could have invoices by hour, which is a nightmare. And we could avoid this by doing as we are currently doing with our client, that every single one of us is working for these clients. So, the invoicing is done on a monthly basis, not an hourly basis. We have, okay, we work this time every month, this amount of hours and this is what we’re going to invoice for example. It’s just something that came across my mind. 

 

Speaker 3: Marta Santos Espada (01:07:22): 

Other pitfalls that we could have oversight. How does our clients trusts that we are going to have an accurate and proper supervision of the activities that our people are going to develop. And here to avoid this, we could have plans agreed with the client, for example, on what are the oversight plans we could have? How can our line managers ensure that our people are delivering what they’re supposed to. We can have, for example, I am the line manager of the CRA group, so I am to schedule visits with them, remote activities with some kind of oversight to ensure to the client that we are keeping things on track, like metrics we can show to the client what type of metrics, what metrics are we accomplishing every month, monthly reports, regular meetings. We could have, I don’t know, weekly meetings by weekly meetings, clinic meetings. Everything is about trust, transparency. So, I think that yes, there are a bunch of pitfalls. Obstacles mostly, is we don’t know you, how can we make sure we trust you? And it’s about transparency, I think. 

 

Speaker 1: Ryan Muse (01:09:20): 

All right. That’s great. Thank you so much. 

 

Speaker 1: Ryan Muse (01:09:24): 

That’s a wonderful answer. I’m sure they really appreciated that insight. We have reached the end though of the Q&A portion for our webinar today. If we couldn’t attend to your questions, know that the team at TFS HealthScience will follow up with you or if you have some further questions, you can direct them to the contact information that’s up on your screen. 

I want to thank everyone for participating. In today’s webinar, you will be receiving a follow-up email from Xtalks with access to the recorded archive for this event. A survey window will be popping up on your screen as you exit, and your participation is appreciated as it helps us to improve our webinars. 

Additionally, I’ve shared a link to view the recording of today’s event in the chat box, which you can also share with your colleagues so that they may register for the recording here as well. Now, please join me once more in thanking our speakers for their wonderful time here today. We hope that you found the webinar informative. 

Have a great day everyone and thank you for coming. 

 

Speaker 2: Harold Nadin: Thanks, Ryan. Thanks, team. 

 

Speaker 3: Marta Santos Espada (01:10:19): 

Thank you, everybody.