Medical Writing

Working with MCS’s skilled, multidisciplinary, medical writing team, you will benefit from the deep knowledge of our organization’s team of scientific experts. These experts are involved in an advisory role to ensure rigorous adherence to the highest quality standards.

Our medical writers work in close collaboration with all disciplines including clinical, bioanalytical, bio-stats and regulatory. The process begins with a thorough discussion with team to explore and articulate strategy and goals. We cover the entire process from drafting, reviewing, and updating to full writing of regulatory documents, supporting with documents that meet all GCP, GCLP and industry standards.

Our medical writing services include:

• Module 2 and 5 (USFDA, HC, EU & ROW)
• ICH E3 compliant clinical study report (CSR)
• Investigator Brochure (IB)
• Manuscripts
• Clinical Development Plan
• Protocol (synopsis) development
• Study, country, and site-specific master informed consent forms (ICFs)