Achieving Global Reach in Clinical Trials: Strategies for Success from a Leading CRO
Designing and running global clinical trials requires planning, resources, and expertise quite apart from running clinical trials domestically. Challenges faced by sponsors running global trials are considerable but not insurmountable, particularly when working with the right contract research organization (CRO) partner should they choose to outsource. Through customized Strategic Resourcing Solutions (SRS), including insourcing or staffing, full-service outsourcing, and Functional Service Provider (FSP) solutions, CROs provide the agility, reliability, and effectiveness sponsors need to meet their clinical research objectives at home and globally.
Global Clinical Trials Challenges
Running global clinical trials requires planning, resources, expertise, experience, and established relationships, quite apart from running clinical trials domestically. The benefits of global clinical trials include having access to more patient populations, among whom are potentially treatment-naïve patients, and the accelerated enrollment of patients from differing clinical situations. In addition, such trials may uncover meaningful internal comparisons and data that can later defend the generalization of study findings. Global clinical trials reduce drug lag, curtail unnecessary duplication of studies, and allow simultaneous rather than sequential submissions, further improving clinical research efficiency.
Challenges faced by sponsors running global trials are considerable but not insurmountable, particularly when working with the right contract research organization (CRO) partner like TFS HealthScience (TFS), which brings the agility, reliability, and effectiveness that sponsors need to meet their objectives everywhere. Challenges in running global trials vary by region and include country-specific patient requirements, differing endpoints required by each country, regulatory requirements that define acceptable study design or endpoint differently, ethnic considerations, language gaps, and cost containment, among others. During implementation, study start-up in each country may be hampered by complex regulatory landscapes, legislation that may need to be updated for new trial designs, e.g., decentralized clinical trials (DCTs) and patient-centric trials with unique supply chain requirements, and delays due to regulatory submissions.
Strategic Resourcing Solutions (SRS) for Global Clinical Trials
Pharmaceutical and biotech companies of all sizes may not readily have talent with the expertise and resources (tangible and intangible, such as country-specific knowledge and strategic partnerships developed over decades-long careers) needed for running global trials in-house. Sponsors may seek strategic resourcing solutions (SRS), which fall into several categories depending on need, including functional resourcing by a Functional Service Provider (FSP), full-service outsourcing (FSO), insourcing or staffing, business process outsourcing (BPO), capacity management, transformational functional, and hybrid solutions.
The FSP model has been utilized in the clinical research industry for over two decades. Between 2018 and 2021, the interest in FSP increased considerably, with utilization going from 28% to 40%. A comparative analysis by TFS reveals that the FSP model is preferred and superior due to its flexibility, scalability, and cost-effectiveness. This finding is consistent with the growing popularity of the FSP model among sponsors, reflected by the growth projection for the global FSP market, a compound annual growth rate (CAGR) of 7.5% from 2023 to 2029. Analysts attribute market growth to increasingly complex clinical trials, the need for cost-efficient and flexible clinical trial management, the strategic focus on core competencies by sponsors, increased R&D spending, and the growing globalization of clinical trials.
TFS Expert Resourcing Solutions
TFS provides sponsors with customized global resourcing solutions that enable the management of global clinical trials that meet their needs for greater efficiency, quality, and flexibility. From a single resource to an entire managed team, TFS delivers quality through talented professionals, intelligent processes, and deep technical expertise. Sponsors can choose short- and long-term solutions for strategic resourcing and recruitment services for permanent hire, with global expertise that crosses all phases and therapeutic areas at all experience levels and competencies. Clinical development functions supported by TFS include clinical operations, project management, pharmacovigilance, biometrics, regulatory affairs, study site coordination, medical writing, and quality assurance.
Sponsors requiring specialized therapeutic or special population expertise can access TFS’s wide range of experience in hematology and oncology, dermatology, immunology and inflammatory diseases, ophthalmology, internal medicine, and neurology, as well as rare diseases and pediatrics, among others.
TFS FSP Model
The FSP model is a personnel sourcing model in which TFS provides staff to sponsors to perform specific tasks —in a dedicated manner— on a contract basis and under the sponsor’s procedures. As modern clinical studies require increasingly responsive solutions, especially if conducted in multiple countries, TFS provides fit-for-purpose FSP solutions uniquely tailored to each sponsor’s needs with a fully integrated and dedicated team to offer enhanced quality, flexibility, and sustained efficiencies. The FSP model enables sponsors to outsource specific functional components of a clinical trial to TFS while retaining strategic control over study data and the overall process. The TFS FSP team also maintains an up-to-date understanding of the evolving clinical trial landscape and successfully leverages tech solutions to meet deliverables effectively.
TFS FSP Case Study
Founded in Lund, Sweden, in 1996, TFS was the first CRO in Europe to offer FSP solutions. Since then, TFS has become a leading company for client-centric FSP solutions with teams based in 17 countries, allowing TFS to support both international and local sponsors. When collaborating with experienced FSP CROs like TFS, sponsors gain access to a more flexible resourcing model that will enable them to maintain better data oversight and benefit from familiarity and team continuity, improving quality and consistency. Further, sponsors benefit from enhanced productivity, streamlined costs by outsourcing their non-core activities, accelerated timelines, and increased control and oversight of deliverables while maintaining quality management oversight and improving market access.
TFS expertise in navigating regulatory and cultural differences
TFS strategically supports sponsors by enabling them to expand their reach with global clinical trials and supplement their projects with selected services to meet requirements at any study phase. Sponsors tap into TFS’s expertise in navigating regulatory environments and cultural differences across regions as TFS keeps up to date with evolving regulations, understands factors that contribute to delay at each stage, prepares for different patient care models (e.g., country-specific standard of care and patient privacy, safety, and informed consent), anticipates and develops contingency plans for clinical supplies and drug supply chain complications, and plans for critical drivers of time- and resource-consuming inefficiencies such as start-up delays.
The problem
This case study is about a global pharmaceutical firm that required swift, reliable, and effective support for its clinical studies. Due to communication challenges and decision delays, they experienced with a larger CRO, they turned to TFS.
TFS – poised and ready
The client benefited from TFS’s unique strategic resourcing solutions and collaborative approach. TFS offered not only agility and quick decision-making typical of a mid-sized CRO but, as a global actor, also ensured the vast reach and operational capabilities typically associated with larger organizations.
The satisfied client
The partnership with TFS enabled the sponsor to seamlessly navigate its tight four-month schedule and achieve its goal of successfully establishing itself in the global market. Given the successful transition of this project, the client is confident in TFS’ abilities and is open to collaborating on future FSP projects in other European countries.
How?
TFS understood the client’s needs, preferences, and region-specific constraints and requirements and delivered a customized FSP solution, which included resourcing a highly-skilled, interdisciplinary team to manage and carry out study activities. Despite stringent timelines, TFS delivered its FSP solution on time while ensuring quality and safety. TFS effectively operated as a seamless extension of the client, overseeing the management of all in-country study activities. Additionally, TFS established a brand new entity in Europe to deliver its FSP solution.
Effective communication, responsiveness, and close collaboration (which the client expressly required) were the norm during the project handover and throughout the clinical studies. In addition, low TFS staff turnover, which all CRO clients appreciate, provided stability and study continuity.
Check out the Meeting the Moment Case Study here. Gain a deeper understanding of the meticulous FSP strategy where TFS left no stone unturned in ensuring safety and quality results.
In conclusion, SRS can help pharmaceutical and biotech companies of all sizes achieve global reach in clinical trials. Sponsors benefit from enhanced productivity, streamlined costs by outsourcing their non-core activities, accelerated timelines, and increased control and oversight of deliverables while maintaining quality management oversight and improving market access.
TFS HealthScience is a leading global mid-size CRO that partners with biotechnology and pharmaceutical companies throughout their clinical development journey. Visit our Resourcing Solutions page to learn more about the TFS Strategic Resourcing Solutions we offer to meet the unique resourcing needs of sponsors, or connect with a TFS representative today!