Medical Writing

Our Medical Writers work closely with the biostatistical, pharmacovigilance, project management, and clinical data management teams to deliver accurate, timely, and cost effective documents to the highest ethical and scientific standards. Our Medical Writers become an extension of your team by being flexible to your scope, using our expertise to guide you through your clinical data and demonstrate the efficacy of your drug and improve patient safety. We have a wide breadth of knowledge and experience drawn from the pharmaceutical industry, clinical research organizations, and academia. All documents produced by MVG Consulting undergo thorough scientific, statistical, editorial and quality control review. MVG’s medical writing services include clinical and regulatory writing, as well as scientific communications, education material and medical writing consultancy. Examples include:

Regulatory and Clinical Writing

• ICH GCP compliant Clinical Study Reports (CSRs); Phases I to IV, including CSR Synopses for public disclosure
• Study Protocols
• Clinical and non clinical sections of the Common Technical Document (CTD) including summaries and overviews for EU and US Regulatory Authorities
• Investigator Brochures
• Patient Safety Narratives
• Patient information including Informed Consent and Patient Brochures
• Pharmacovigilance documents such as Periodic Safety Update Reports