The presenters will discuss how different regulatory and operational strategies were employed to optimise trial efficiency, minimise regulatory review timeframes and maximise recruitment efforts of early phase patient studies.
TORONTO (PRWEB) July 13, 2020
In this webinar, members of Simbec-Orion’s specialist early phase Project Management team will discuss how they tackled a range of challenges to successfully execute a variety of Phase I clinical studies in patient populations.
The presenters will discuss how different regulatory and operational strategies were employed to optimise trial efficiency, minimise regulatory review timeframes and maximise recruitment efforts of early phase patient studies. These will be demonstrated via a number of case studies including:
- A First-into-Human study combining healthy volunteer and rare disease patient population parts within the same protocol
- A human pharmacology study involving patients with neurodegenerative disease
- A gamma-scintigraphy imaging/inhaled drug lung distribution study in patients with moderate and severe chronic obstructive pulmonary disease (COPD)
Join Nadine Aawar, Director Project Management, Laura Llewellyn, Project Director, and Laura Galligan, Project Manager at Simbec-Orion in a live webinar on Wednesday, July 29, 2020 at 9am EDT (2pm BST/UK).
For more information or to register for this event, visit Phase I Studies in Patient Populations: De-risking Clinical Development by Obtaining Key Patient Data Earlier.
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