When your clinical trial is in distress, you don’t have time to waste. You need a partner
with experience and know how to get your studies back on track and bring them to
completion. Caidya has successfully delivered 26 rescue studies in the past five years
alone, with nearly half of those being global.
Equipped for Rescues
The keys to our success with rescue studies rest in the combination of preparedness
and adaptability. With a deep understanding of critical transition considerations, our
rescue experts utilize the Caidya Transition Blueprint to provide immediate structure to
the process. But a blueprint alone is not enough because no two studies are exactly
alike. We also bring our trademark adaptability to adjust as the situation requires.
Key Considerations
When transitioning a rescue study, we not only gain a full understanding of the specificissues unique to that study, but we also bring knowledge of key considerations whentransitioning any rescue study, including:
- A detailed transition plan and gap analysis
- Open communication with the sponsor and the incumbent CRO
- Ensure a complete knowledge transfer
- Detailed disclosure of what needs improvement
CRA transition with minimal disruption
- Transfer of regulatory submissions/obligations
- Quality considerations – Audits (TMF, processes, etc.)
Blueprint for Success
With a constant eye on where we need to flex, our experts apply the Caidya TransitionBlueprint to quickly and effectively move your study from transition to independence.Our phases include much detail, and consist of:
- Transition kick-off
- Knowledge acquisition
- Transition implementation (Wave 1, 2 and 3)
- Independence