Concept Protocols: An Insider's Guide to Efficient Study Design

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Concept Protocols: An Insider's Guide to Efficient Study Design

April 7, 2025
 - Tim Hardman
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Tim Hardman

Managing Director
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Dr Tim Hardman is Managing Director of Niche Science & Technology Ltd., a bespoke services CRO based in the UK. He is also Chairman of the Association of Human Pharmacology in the Pharmaceutical Industry, the representative industry body for early for early phase clinical studies in the UK, and President of the sister organisation the European Federation for Exploratory Medicines Development. Dr Hardman is a keen scientist and an occasional commentator on all aspects of medicine, business and the process of drug development.

Concept Protocols: An Insider's Guide to Efficient Study Design

This resource from the Niche medical writing team offers insights into the benefits and best practices for creating concept protocols in clinical research.

It emphasizes that these short, flexible documents facilitate early team alignment and discussion on study design before extensive resource investment. The guide offers advice on what to include and exclude in a concept protocol, highlighting the importance of brevity and focusing on key study objectives and design elements.

Furthermore, it touches upon the evolving role of large language models in drafting protocols, noting their potential to expedite certain sections while underscoring the necessity of human oversight.

Ultimately, the source advocates for the use of concept protocols as a way to improve the efficiency and quality of full protocol development by addressing critical aspects early in the process.

April 7, 2025
 - Tim Hardman

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