Kevin Bishop, VP, RTSM, Bioclinica
Duration: 1 hour
Although often not a component of the initial study plan, a contingency plan can be needed if a study is transitioned because of acquisition at the sponsor level, performance/capability issues or study re-design. When addressing this type of transition or “rescue” scenario, it is important to recognize the unique challenges that a study team will face. Because study conduct is already underway, the focus shifts beyond initial study implementation to the entire study process, requiring meticulous planning for simultaneous transition of administration, logistics and technology, as well as project and data management. Effective, efficient transition of study conduct requires consideration of not only the sponsor, CRO and associated service providers but also particularly the study sites, to avoid losing or potentially to regain or energize participating sites.
Download our on-demand recording to learn more about:
- Key considerations and learned lessons when transitioning mid-study
- Resource requirements for rapid deployment
- The effect of study stage on patient safety and regulatory considerations