Regulatory


The central key point of a clinical trial is its approval by regulatory authorities and ethic committees. Our clinical team provides a clear path to trial approval by ensuring complete, accurate and timely document submissions in compliance with European and national requirements. Our clinical team is fully trained for submission using the new CTIS portal following the Clinical Trial Regulation (CTR 536/2014) and has excellent relationships with health authorities to ensure smooth and rapid preparation of the dossier.

 
Our services include :

  • Core document development and preparation

  • CA/EC submission and  answer to questions

  • Amendment management

  • Annual reports and notification to CA/EC

  • Public clinical trial registration


 


 

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