Biospecimen data plays a pivotal role in all phases of drug development.
During the early stages, it determines dosing regimens, evaluates initial safety and efficacy, and helps understand potential patient variability. This stage also drives go/no-go decisions and lays the groundwork for subsequent phases.
As trials progress from Phase 1b to Phase 3 and expand from single research units to multi-site efforts, challenges intensify with transitions in study leadership and operations.
Access the recording of our panel of seasoned clinical pharmacologists, offering real-world expertise, as they delved into strategies for navigating the shift from early-stage research to Phase III clinical trials.
Topics include:
Risks and costs linked to biospecimen mismanagement across development stages
Early detection and intervention strategies for protocol deviations
Common factors contributing to anomalies in PK curves
Collaborative approaches between clinical pharmacologists and operations for a successful transition from early to late-stage trials
