临床试验中外包服务（FSP）的交付模式

Ensuring quality and inspection readiness are pivotal sponsor responsibilities integral to the outsourcing model. As the complexities of trials evolve, access to data and control over key trial decisions are becoming more important. Today’s outsourcing models offer you even greater flexibility and more options that instill confidence while balancing the amount of direct day-to-oversight, shared risk and governance.

Parexel helps you design a personalized model, guiding the number and type of internal resources required to manage the relationship while establishing and measuring key performance indicators (KPIs).

The success of a development portfolio requires rapidly adjustable work volume and the right resources where and when you need them. We ensure access to the talent, resources, and technologies you need to succeed. Our global reach guarantees therapeutic and functional expertise in all major markets around the world.

As your provider, we will readily fill internal gaps in specialist expertise with a strong cultural resource fit, ensuring confidence to meet changing demand without shouldering the cost and liabilities of additional permanent employees.

Trials have become increasingly nuanced with the evolving demands of sophisticated treatments and complex research, requiring the development of expert staff and programs to recruit, train and retain a new generation of experts.

Parexel’s dedicated FSP trainers and Academy program build and execute continuous industry, therapeutic, asset and procedural training that is aligned to your pipeline and technology stack. Focused on a single global standard, we enable leveraging a diversified geographic footprint without compromising on performance. Training and development responsibilities are built based on your needs.

Geographic diversification is a core strategy to achieve a cost-stable talent pool and access patient populations. Clinical trial infrastructures in many countries are quickly evolving, requiring a footprint in regions where a strong foundation may not exist.

Parexel works with clients to provide a location strategy and maximize breadth of knowledge and experience within locations, relative to expertise required, therapeutic area, indication knowledge, and study design types. A balanced approach could include cross-functional study delivery or building hubs of talent that seamlessly integrate into your global team of decentralized roles.

Through an outsourcing model, you’ll be able to tap into additional therapeutic and indication-specific expertise. Across all our therapeutic areas, Parexel combines innovative trial designs, leading clinical and regulatory expertise, global reach, and a passion for changing patient lives to propel your treatments.

Our therapeutic expertise and broad knowledge of the underlying mechanisms of diseases, paired with our vast global operations, enable our multidisciplinary team to respond quickly to your most critical demands.

In this new outsourcing ecosystem, various FSP approaches offer flexibility and options regarding pricing, oversight, shared risk and governance. Outsourcing can be used for staff augmentation or designing a programmatic strategy with the CRO fully managing individual functional delivery. The right balanced model enables you to maintain control and oversight while accountability remains with the clinical research organization.

Parexel’s FSP expertise and scale can help you identify opportunities to optimize your approach, helping you turn fixed costs into variable costs without sacrificing quality.