重新定义战略外包：建立推动创新的伙伴关系

Forward In today’s complex clinical trial landscape, agile outsourcing solutions are emerging to help bringinnovative products to market more quickly and cost-effectively. At Parexel Biotech, we understand That’s why we’ve moved beyond the one-size-fits-all outsourcing approach to offer a holistic viewthat considers all functions within your organization and the interconnected nature of our industry. We’ll work with you to develop a comprehensive outsourcing plan that delivers cost efficiencies,helps you demonstrate proof of concept, and generates the evidence necessary to earn investor With Parexel as your strategic partner, you gain: Access to comprehensive therapeutic expertise backed by proven study experience Increased resource flexibility across a global network Cost efficiencies through optimized resource allocation Apartnercommitted to both operational excellence and comprehensive strategy This playbook will walk you through key considerations for developing an agile outsourcing strategy Sincerely, Jenny DenneyExecutive Vice President, Global Head FSP A holistic approach to outsourcing Biotech companies, as life science innovators, face unique challenges and opportunities. Whiletheir agility and specialized expertise continue to fuel promising pipelines and new therapies, To thrive in this competitive landscape, many companies are pivoting towards a more strategic,holistic outsourcing approach that moves beyond the traditional full-service model and betteraligns with their long-term goals. With insight into the current and evolving market landscape, Whether seeking to out-license a compound, enter the clinic, reach proof-of-concept orcommercialize decisions made at the asset level will shape the structure of your outsourcing model: Infull-service outsourcing (FSO), the CRO reduces the sponsor’s operational burden byconducting the clinical study, providing the functional downstream services, including project Infunctional service provider outsourcing (FSP), a CRO handles specific functions or servicesacross clinical trials, integrating seamlessly with internal teams to bridge resource gaps. Sponsorsaccess critical functional expertise and talent that best fits their organizational culture, with CRO While pure FSO and FSP models work for some biotechs, we’ve found that many may benefit from a bespoke hybrid approach combining the best elements of both. Theoptimal model — whether full-service, FSP-based, or hybrid — depends on expected pipeline growth, the number of studies and indications, and clinical development stage. Designing the model Based on these core questions, the following key challenges and opportunities will guide youroutsourcing strategy and help you design a partnership that amplifies your current capabilities by Core strengths Technology preferences Rather than building out the procedures, systems,and large teams necessary for conducting studies,biotechs may opt to outsource clinical services— leveraging a full-service model that reduces Many biotechs are centralized in a single location,with limited or no presence outside of homecountries. In such cases, hybrid outsourcing allowsa sponsor to use an FSP-based approach in itsprimary location, where resources are strongest,and opt for a hybrid approach in countries where The choice of model should align with a company’scurrent technology capabilities and long-term Would you prefer to build and maintain your ownsystems as provided by FSP and common in ahybrid model? Or could you benefit from CRO-provided innovation that can be part of bothFSO and hybrid models? Your choice should beguided by your current capabilities and long-termstrategic technology vision. In-house technology Adapting asyou mature Emerging biotech companies may opt for full-service outsourcing to support a smaller pipeline ofone or two trials or to supplement their team in anticipation of portfolio growth. However, as theygrow their portfolio and capabilities, these companies may want to explore FSP-based solutions. Staff augmentation, which allows you to expand yourteam without the complexities of direct hiring. Biometrics, including data management, biostatistics and statistical programming,and medical writing, which can be efficiently and cost-effectively managed Regulatory and safety operations, providing access todomain expertise while reducing infrastructure costs. FSP outsourcing offers increased resource flexibility across different regions with dedicatedfunctions and talent to drive cost efficiencies at scale. With a view into common challenges,CROs like Parexel have the expertise and scale to identify opportunities to optimize the FSP model.Parexel works collaboratively with your organization to design a bespoke outsourcing model that Enlisting theideal partner The right CRO partnership transcends traditional outsourcing — it becomes an extension of yourvision and capabilities. When evaluating potential partners, consider str