Planning Your Clinical Trial: The Pros and Cons of Outsourcing Your Biometrics Function

This whitepaper compares internal, outsourced and hybrid biometrics models and explores the different outsourcing structures available to biotech organisations. It explains how factors such as study complexity, internal expertise, funding, data sources and study design can influence the capabilities required to support a successful clinical trial.

This Whitepaper will provide you with:

• Understanding of the key biometrics functions - including biostatistics, clinical data management, statistical programming and data standards.
• Knowledge of internal, outsourced and hybrid operating models - including the advantages, limitations and practical considerations of each approach.
• An understanding of different outsourcing models - from individual specialist resources and staff augmentation to FSP, full outsourcing and strategic partnerships.
• Insights into how study design and data sources affect biometrics needs - including real-world data, digital endpoints, decentralised trial elements and artificial intelligence.
• Key considerations for effective governance - covering roles and accountability, escalation, quality control, change control and risk management.
• Practical guidance for moving from decision to study start - including partner evaluation, decision rights, governance structures and communication processes.