Medical Writing

FMD K&L can assist in developing protocols, informed consent forms (ICFs), clinical study reports (CSRs), and other study-related documents
Clinical Operations: Overview

Medical writing plays a crucial role in drug development. Regulatory agencies demand accurate, error-free documentation and reporting. The consequences of a rejected submission are lost time and lost revenues.

FMD K&L provides exceptional medical writers who can assist in compiling, organizing, writing, editing, and producing an array of medical and scientific documents. For every medical writing project, large or small, we provide rapid turnaround and a quality-controlled process ensuring accuracy.

Our medical writing services include:
  • Protocols
  • ICFs
  • CSRs
  • Pharmacovigilance reports
  • Clinical sections of common technical documents (CTDs) & new drug applications (NDAs)
  • Investigator brochures & annual updates
  • Benefit/risk assessment reports
  • Medical & scientific literature reviews

All our medical writing services are available on a project basis or as part of an end-to-end solution for an entire clinical development program. Many of our medical writers have advanced life sciences degrees. We provide medical writing in a variety of languages for global submissions.