Take the reviewer perspective
Getting clinical outcome assessments endorsed by the FDA is challenging and requires persistent critical thinking from early conception to delivery of the evidence dossier. Nothing should be overlooked. Insight is key. Conveying your decisions with confidence and building the supportive evidence without getting lost in the details or missing the big picture require clear strategic ability.
- Approach regulatory submissions thinking strategically from the perspective of the reviewer
- Design convincing evidence dossiers to demonstrate that clinical outcome assessments have content validity in the context of use, satisfactory measurement properties, and are interpretable
- Prepare and actively participate in regulatory discussions (FDA and EMA)
- Lead qualification of clinical outcome assessments
Copyright © 2014 TwoLegs Consulting LLC, All Rights Reserved