Medical Writing

Clinical Trial Medical Writing

A grounded scientific approach for your study that’s setting the industry standard.

Medical Writing Services: Two Distinct Models

WCCT’s scientific advisers and biostatisticians work with you to develop a sound scientific approach to your program or study. Our services include two distinctly different medical writing models. As a global company, we offer onshore and offshore clinical trial medical writing services.

Both models provide the same types of services; all led by our experienced staff, utilizing state-of-the-art processes and quality standards. With WCCT you will have a custom clinical trial medical writing plan that best suits your unique needs.

We can provide all the essential clinical trial documentation:
  • Clinical study protocol and amendments
  • Investigator’s Brochure
  • Informed Consent Form
  • Clinical Study Report (CSR)
  • Patient narratives
  • IMPD, eCTD and regulatory briefing documents
  • Integrated Summary of Safety/Efficacy
  • Case Report Forms
  • Pre-IND packages
  • IND submissions/FDA meeting notes
  • Annual and final study reports
  • NDAs
  • BLAs and PMAs
  • Product assessments
  • Gap analyses
  • Medical alert letters

Why Choose WCCT’s Clinical Trial Medical Writing Service

Operational Excellence

A proven process that starts with incorporating new trial data as it becomes available and planning ahead for all FDA interaction.

Writing Expertise

Experienced writers plan and produce clinical protocols, study reports, and overview documents to meet your timelines, while ensuring consistency and quality across the development program.

Quality That Is Evident

Our client satisfaction ratings are so high that 92% of the sponsors we do business with do business with engage us again.


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