Medical Writing

Agility’s medical writers have a wide range of experience in drug development, including small and large molecules, biologics, diagnostics and devices. Our medical writing team works closely with clinical team members to develop quality clinical documents. We use ICH compliant templates and deliver all documentation in electronic format, according to sponsor specifications. Documents produced by Agility are thoroughly reviewed by our medical, statistical, and editorial teams and undergo a comprehensive quality review process. Examples of our medical writing services include:

  • Protocol development and review
  • Investigator brochure development, review, and update
  • Development of clinical study reports (CSRs)
  • Development of integrated safety and efficacy summaries
  • Quality control (QC) review of documents provided by the sponsor (eg, QC of CSRs)