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International Clinical Trials

Outsourcing Trial Applications

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The complexities and national nuances of the competent authority (CA) clinical trial application (CTA) process across EU countries often lead sponsors, especially those based outside the EU, to outsource CA CTA submissions to service organisations within the EU. The decision to outsource gives rise to several items for the sponsor to consider. What outsourcing model will be the best fit? How will trial-related legal requirements be met? Do core trial documents adhere completely to EU guidance? How will the timing of each CA submission fit in with any other planned regulatory activities in the EU? What will be needed for the UK post-Brexit? These considerations need to be addressed in good time to facilitate an efficient submission process and correspondingly rapid approvals for clinical trials.

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About the author

Paul Carrodus is Director of Regulatory Services at TMC Pharma Services Ltd. He is a regulatory affairs professional with over 14 years’ EU regulatory experience working in major pharma and clinical research organisations. Paul’s expertise spans all aspects of regulatory affairs, from early drug development to post-marketing support, including regulatory strategies, MAAs, and lifecycle maintenance support, scientific advice, orphan drug applications, paediatric investigation plans, clinical trial applications, and medical writing.

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