The success of a clinical trial depends on the many individuals (such as study coordinators, CRAs, etc.) who play specific roles to move it forward. As with any team, a breakdown in communication or inability to deliver what is expected of one member affects every member. However, there is no room for error in clinical research, where missteps may affect the lives of patients, current and future. Sponsors often will consult or work with Contract Research Organizations (CROs) to help manage their clinical trials and that’s exactly what one sponsor did in the case study we break down below. Realizing they needed a better solution for their oncology-hematology clinical trial, a new client approached TFS HealthScience, a global, mid-size CRO, with several challenges that needed solving.

This article highlights a case study where TFS successfully approached and managed our client’s challenges and found solutions to complete their study. 

 

Problem Identification  

A new client (sponsor) came to TFS and described their challenges running a multi-region Phase III oncology-hematology study. To view the problem in its entirety, our team worked with the client to identify all their pain points, what was working well, and the areas that needed adjustment. Our team needed to determine the cause of their pain points and understand how they were interrelated to ensure we would not plug one gap while risking another. Based on the findings and consultation with our team experts, we identified the client’s needs, our priorities in developing a comprehensive solution, and the right resources for the task.

 

The Role of Study Coordinators  

The engagement of a study coordinator was an integral part of our strategic resourcing solution (SRS) for our new client. In the sections that follow, we explain how our solution met the client’s needs and exceeded their expectations.

Why was a study coordinator crucial for this clinical trial? Study coordinators have a wide range of responsibilities and perform activities essential to the smooth conduct of clinical trials. Coordinators are the main point of contact for research participants and the sponsor’s project management team. They ensure the safety and well-being of participants throughout clinical trials and contribute to administrative, monitoring, research-related, and clinical activities. Amidst a rapidly evolving research ecosystem, increasingly complex trial designs, and challenging regulatory requirements, the demands and expectations of study coordinators have increased, requiring additional skills, training, and medical knowledge. A study coordinator was necessary for the success of this clinical trial and with TFS’s strategic resourcing solutions (SRS), we were able to fill the role with the most qualified study coordinator for this trial’s unique needs.

 

Key Challenges Faced by the Client

1. Data management dilemma

The client was overwhelmed with keeping current with enrolled participants and entering data into the trial database. They were aware and concerned about the consequences of incomplete data – how not having accurate and reliable data would affect safety monitoring, internal decision-making, e.g., whether to proceed with the study, and regulatory submissions, amongst others. Collaborating with the client, TFS identified an additional issue that contributed to this problem: a lack of clarity in the roles and responsibilities of different stakeholders and potentially a lack of knowledge and experience in data management practices. This challenge is not uncommon.

TFS solution for maintaining data integrity 

Data management, which involves the collection, organization, and analysis of data generated during clinical trials, is vital for trial success. TFS study coordinators ensure data is captured accurately and securely by maintaining sound source documentation practices. Depending on the study, coordinators may analyze the data and report findings. Additionally, they manage all central and local laboratory reports. Study coordinators are adept at using electronic data capture (EDC) systems, further enhancing accuracy and efficiency while streamlining communication with sponsors and other study stakeholders. 

The study coordinator TFS hired for the client underwent our rigorous selection process. Nevertheless, the ability to ensure that database set-up, data entry, and statistical analysis comply with regulatory requirements and Good Clinical Practice (GCP) guidelines and to ensure the accuracy, integrity, and reliability of clinical trial data is a core skill of all study coordinators in our SRS network. Further, our study coordinators are adept at developing data entry standard operating procedures (SOPs), training the study team, and recognizing and escalating data quality trends as appropriate. TFS study coordinators have the added advantage of access to a comprehensive data surveillance and risk monitoring tool that improves data quality and promotes patient safety in clinical trials. Further, AI-driven insights and task automation reduce the time to high-quality data and bring operational teams closer.

Although the client was focused on their data management woes, we clearly heard their desire to better serve their patients as well. One of the traits of our network of study coordinators is continuous learning, which keeps them well-prepared to foster patient engagement and facilitate the design and implementation of innovative trials, such as patient-centered trials. Patient-centricity benefits participants in terms of convenience and reduced participation burden.

 

2. Communication breakdown

Recounting their experience, the client felt they were often left in the dark due to inadequate communication between clinical trial sites and their study team. They attributed this gap to the high workload at sites and the apparently low priority monitors gave to staying engaged with site staff. Though the monitors occasionally visited sites, the client felt they did little to address concerns or resolve any doubts. In collaboration with the client, we determined that a lack of clarity in roles and responsibilities, similar to the first problem, was the root of the issue. One of our main priorities was solving this problem and ensuring that the right person with the right skills was assigned the proper role. Providing a solution to this and related issues would also alleviate the high workload at sites observed by the client.

TFS solution for improving communication   

Experienced study coordinators are keenly aware of the importance of strengthening communication and developing collaborations with study sponsors, monitors, and clinical research sites. TFS study coordinators bring the added value of working and nurturing collaborative relationships with stakeholders in the clinical research ecosystem, including research sites, vendors, and ethics boards. Further, they invest in forming collaborations with investigators and other teammates by providing support and ensuring seamless study execution. Equally important, study coordinators keep participants involved and informed by providing updates, clarifying study procedures, risks, and benefits, and responding to questions and concerns.

 

3. Study complexity & trial efficiency

Due to the study’s complexity, the client discovered that day-to-day clinical trial management required a lot of time.

TFS solution for trial efficiency   

Understanding that the client’s need for improved communication is related to trial efficiency, we assured the client that in addition to making certain that clinical operations comply with regulatory requirements, TFS study coordinators are equipped to address operational challenges to increase trial efficiency while maintaining high quality. Among their tasks, study coordinators manage schedules and timelines to stay on track, coordinate vendors and multiple sites for smooth operations, and provide care and coordination of participants throughout their trial journey. They improve trial efficiency by centralizing coordination tasks and streamlining trial operations. Further, they understand budget components, manage the trial budget and resources, track expenses, implement prudent financial management, and keep within the allocated financial parameters and timelines.  

 

Study Coordinators & Study Strategy 

Allow TFS to Overdeliver and Plan ahead. 

Study coordinators are meticulous from start to close, paying attention to detail from beginning to end. However, study coordinators are not limited to administrative tasks. They are part of the strategic planning of clinical trials, contributing to site selection, timeline estimation, and contingency planning. Throughout the strategic planning process, for example, study coordinators ensure that measures are in place for compliance with all regulatory standards. 

Moving forward with their study, the client can expect that the TFS study coordinator will contribute at the strategic level. In times of unexpected change and challenges, study coordinators will help adapt strategies and plans to stay on course.

To consistently care for study participants and contribute to developing innovative life-saving interventions, forward-looking study coordinators keep up to date with the evolving clinical research environment. Emphasizing continuous learning and professional development, advancing their skills, learning about changes in regulations locally and abroad, and being aware of new tech and methodologies, TFS study coordinators continue to bring value to participants, sponsors, and clinical research.   

 

TFS’s Strategic Resourcing Solutions (SRS) 

In summary, TFS provided the following solutions: 

1. Hired a Study Coordinator for the Client. Through our rigorous screening process and onboarding strategies, TFS’s SRS team hired a study coordinator who not only had the skills to move the study forward but also fit the structure and culture of the client. With our tested screening process and onboarding strategies, we delivered the talent the client needed to support their most time-sensitive tasks. The TFS quality oversight and governance plan enabled TFS to exceed expected key performance metrics and timelines regularly.
2. Maintained Data Integrity. The study coordinator ensured data was captured accurately and securely by maintaining sound source documentation practices. To ensure the continuity of the study, the trial database was kept updated, starting with the most recent patient visits.
3. Enabled Patient Focus. The study coordinator kept track of the study cycle and participant follow-up visits and worked towards reducing participant burden.
4. Established Communication Channels. The TFS study coordinator responded to the many queries that had been amassed over time, followed by connecting and strengthening communication between the research staff and the sponsor.
5. Improved Trial Efficiency. TFS study coordinators addressed operational challenges to increase trial efficiency while maintaining high quality.
6. Allowed Zooming In and Out. In their toolbox of skills and capabilities, study coordinators are meticulous and pay attention to detail, as well as the ability to think and plan strategically. They possess organizational, management, planning, communication, problem-solving, and mediation skills and invest in continuously expanding their skills. TFS study coordinators were committed, proactive, and willing to do all they could to progress the study forward successfully.

 

Client Feedback 

Based on the process of jointly developing a solution to address their challenges and the outcomes of working with TFS, the client was grateful for the work and effort dedicated to their study. Methodically, each of their challenges was clarified, understood, and addressed. The trial database was brought up to date, patient visits were managed well, which improved patient engagement, and communication was strengthened as they had hoped. Overall, the client responded that the TFS solutions positively impacted and eased the burden of their challenges. With the challenges they were having, the study could have ended much differently had they not been addressed. With the right strategic solutions and CRO services, this study was saved.

 

Your Strategic Resourcing Solutions Partner

Does your clinical trial require additional resources? TFS strategic resourcing solutions provide customized global resourcing (employment) solutions that enable organizations to manage their clinical trials with greater efficiency, quality, and flexibility. From a single resource like a study coordinator to an entire managed team, we deliver quality through our talented professionals, intelligent processes, and deep technical expertise. We offer short- and long-term solutions for strategic resourcing and recruitment services for permanent hires, with global expertise that crosses all phases and therapeutic areas at all experience levels and competencies. 

TFS HealthScience is a leading global mid-size CRO that partners with biotech and pharma companies with tailored clinical development and resource solutions throughout their clinical development journey.  

Contact us to discover how we combine a large CRO’s full-service capabilities and global reach with the flexibility and personal approach only a mid-size CRO can deliver.