Medical Writing

Medical Writing

Medical writing at GRC is integrated with our Medical Monitoring, Pharmacovigilance, and Biostatistics teams. This collaboration ensures scientifically accurate and regulatory-compliant documentation for clinicians, researchers, and regulatory agencies.

Our team includes Veteran Clinical Researchers, Biostatisticians, and Bench Scientists who produce medically and scientifically sound writing across drugs, biologics, and medical devices. We specialize in areas like proteomics, epidemiology, and pharmacogenomics.

GRC adheres to document management procedures and electronic submission standards, ensuring regulatory compliance. All documents undergo rigorous quality assurance review before delivery, guaranteeing accuracy and clarity. Our Medical Writing Services include: We develop comprehensive study documentation to outline all steps of the data management process, including specific procedures such as the Data Management Plan (DMP), Data Validation Plan (DVP), validation checks specifications, SAE reconciliation, and medical data coding. Our Data Management Services include:

  • Literature Reviews:
  • Abstracts/Presentations:
  • Protocol Writing:
  • Informed Consent Form Development:
  • Investigator Brochure (IB) Development:
  • Leaflets, Case Reports:
  • Clinical Study Reports (CSR):
  • Advisory Board Support:

 

With GRC’s expertise, clients receive clear, scientifically sound documentation supporting successful clinical research and regulatory submissions.