Résumé
Examining best practices in using the functional service provider model for clinical operations, pharmacovigilance, regulatory, and other areas The COVID-19 pandemic has shown that there's a lot more flexibility in clinical trial systems than what was realized in the past. Some of these and other aspects leading to the rise of FSP outsourcing in drug development has been shared by other experts as well.3 Key functions and sub-functional areas within clinical development that have been outsourced as part of FSP model include: * Clinical monitoring (CM) * Clinical data management (CDM) * Biostatistics, statistical programming (BS&P), data standards, conversions (e.g., CDISC) * Medical writing (MW) * Pharmacovigilance/drug safety (PV) * Regulatory affairs (RA) Based on our experience in advising clients and providing FSP/CRO services over the past 20 years, we have seen the creative bundling of some of these functions as part of the extended FSP partnership model. * Combination of CDM, BS&P, and data conversions * Extension of the CDM, BS&P, and MW into a "clinical data services' package * Combination of clinical monitoring, CDM, BS&P, and medical monitoring into a "centralized monitoring team" (potential future services) * Combination of PV and regulatory activities due to regional synergies and submission/compliance requirements (potential future services) To ensure that the FSP model is strategic and provide the sustainable mode of partnership, we have shared some of the best practices ahead (and summarized in Figure 1 above) that can be leveraged and further customized as needed by sponsors: 1.Functional sourcing strategy: Sponsors must include specific criteria as part of their evaluation of service providers for the FSP sourcing plan (some of these are also typically done during a full-service CRO outsourcing process): Size and geography focus of provider that needs to be aligned with the strategic plans of the sponsor (e.g., where they plan to conduct trials to meet their regulatory needs or the size of stud ies). Team strength, capacity, and experience with both FTE and unit/deliverables-based pricing models of delivery. * Commitment to deliver year-over-year productivity gains using automation, digital/AI/ML technologies, and other approaches. * Partnership approach to play a critical role in initiating, driving/participating in innovation, and transformation initiatives of the sponsor. * Past client and employee turnover (attrition) that should be on par or below benchmark for the same function and similar type of service. * Executive commitment to participate actively in joint-governance discussions that ensures proactive monitoring and tracking of the program milestones and drive mitigatory actions, should milestones not be delivered on time, quality, and cost. 4.RFI/RFP process, joint solution development, and rigorous scoring of proposals and solutions: