Clinical Services


Medical Writing & Submission

GCTRO uses a blended model for Medical Writing to give our sponsors the best quality to ensure well crafted and written reports at the most competitive prices. Our US based team is highly experienced in writing documents for IND, NDA, PMA (drug-device), BLA, ANDA, MAA, and post-marketing applications. We compile, organize, write, and edit a range of high-quality regulatory and publication documents. Our medical writing services are cost effective, flexible, and seamlessly integrated with the corporate writing style and needs of our clients.

Our services for Medical Writing spans across the following categories:

Protocols

Clinical Study Reports (phase I - IV)

Investigator’s Brochure and Updates

Informed Consent Documents

SAE Case Narratives

Periodic Safety Update Reports

Abstracts and Manuscripts

Posters and Presentations