Clinical trial sponsors are required to file a CTA for review and approval before they can start a new trial.
CTAs are required for trials involving human participants, including trials in Phases I through III of product development and bioavailability studies.
Our interdisciplinary team combines experience in regulatory affairs, data management, medical writing, project management, and biostatistics, to ensure your clinical trial applications meet the highest standard possible while being specifically tailored to your trial’s needs.
Our services support the preparation of:
- Clinical Trial Applications
- Clinical Trial Application Amendments
- Clinical Trial Application Notifications
Contact us for assistance with your clinical trial applications