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PRODUCT CHANGES

The need to make changes to an investigational product after the clinical study has started is always a dilemma. Sponsors should therefore be prepared to justify that the design or formulation change will not affect the validity of the study data or the ability of relevant results to be pooled.

Donawa Lifescience Consulting (DLC) can assist with describing and notify changes. Relevant national laws and guidance documents will be identified and contacts with local Competent Authorities and Ethics Committees made to determine the specific requirements for managing changes and any related timeframe for notification or submission of information.

Please contact us for further information or assistance.