Proactively planning for additional study elements gives greater flexibility, allowing you to make decisions based on emerging data, without requiring additional regulatory approval.
TORONTO (PRWEB) May 12, 2021
In early clinical development, making changes to a study design after regulatory approval can cause significant delays. These can be avoided by incorporating additional/optional study parts into the original protocol. Proactively planning for additional study elements gives greater flexibility, allowing you to make decisions based on emerging data, without requiring additional regulatory approval.
Join experts from Simbec-Orion, Dr. Simon Hutchings, Director of Pharmacology; and Dr. Danielle Francome, Senior Pharmacologist, in a live webinar on Thursday, May 27, 2021 at 10am EDT (3pm BST/UK) to discover how an adaptive, multi-part, First-in-Human (FiH) study design can accelerate your early clinical development. The speakers will provide insights on:
- Working with your CRO to design an adaptive, multi-part, FiH study
- Adding maximum value to your FiH protocol by answering key human pharmacology questions via flexible and optional study parts (e.g. food effect, DDI, formulation, posology, target engagement, gender/age effect, TQT assessment, Proof of Concept)
- Additional considerations for FiH to patient multi-part studies
- Theoretical and case study examples
- Considerations for budgeting
For more information, or to register for this event, visit Accelerate Early Clinical Development with Adaptive, Multi-Part, First-in-Human Study Design.
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