CLINICAL SUPPLY MANAGEMENT RESOURCES

• The Crucial Role Of IRT/RTSM In Optimizing Drug Supply Budgets

  Expand your knowledge of IRT/RTSM systems and their capabilities to tailor supplies to site-specific recruitment, significantly decrease drug waste and costs, ensure efficient IMP management, and more.

• Study, Not Software: Aligning RTSM To The Protocol

  How can RTSM platforms improve your clinical trial and how do they integrate with your crucial trial systems?

• What Are Decentralized Clinical Trials (DCTs)?

  Discover how DCTs leverage “virtual” tools, such as telemedicine, sensory-based technologies, wearable medical devices, and direct delivery of study drugs and materials to patients’ homes.

• Leveraging The Bolar Exemption To Accelerate Market Access

  Gain insight into the changing comparator sourcing landscape, focusing specifically on the instrumental role the Bolar exemption plays in the shift away from dependence on innovators for clinical supplies.

• Master Protocols: Implementing Effective Treatment Adaptations

  From balancing treatment ratios and managing eligibility to accommodating site-specific readiness and protocol amendments, a well-designed IRT system enables seamless transitions.

• Building Better Resilience Into Your Clinical Supply Strategy

  Reliable clinical supply requires proper vendor selection, cross-functional communication, and safety nets built to accommodate an ever-changing geopolitical and global pharmaceutical landscape. To avoid supply disruptions for clinical drugs, sponsors must give clinical supply its proper weight in initial protocol development and trial design.

• Best Practices For Randomization And Trial Supply Management (RTSM)

  This white paper represents a compilation of industry best practices for designing, implementing and leveraging randomization and trial supply management (RTSM) software in clinical trials.