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Expert Medical Writing For Your Every Need

Regulatory Documents

Our medical writing experts can help you tailor a complete range of regulatory documents that open doors to the future success of your project.

  • Protocols
  • Study Reports (CSRs/CTRs and NSRs)
  • Investigator’s Brochures (IBs)
  • Clinical submission documents
  • Briefing documents
  • Layperson summaries
  • Pediatric Plans (PIPs and PSPs)
  • Q&A documents
  • Danish Medicines Council applications
  • Device Documents: CIPs, CIRs, and CERs

Review, Training, and Processes

We can provide further expert support with:

  • Review of scientific and medical promotional material
  • Training and workshops in medical writing
  • Processes and template development

Publications

Our publication experts can help you create awareness of your results, innovations, and discoveries in the scientific community.

  • Manuscripts for peer-reviewed journals
  • Systematic literature reviews and meta-analyses
  • Conference abstracts, posters, and oral presentations

From standalone to full-service projects, our flexible experts apply a wealth of experience from the pharmaceutical industry and academia across multiple therapeutic areas and product types to develop your regulatory documents and scientific publications to deadline, saving you time and money.

10+ Years Medical Writing Experience

17+ Years Pre-clinical and Clinical Research Experience

PhD Level Experts Deeply Rooted in Science

Broad Therapeutic Experience – Oncology (50%) and Rare Disease (10%)

Protocol Writing with Extensive Experience for Early (60%) and Late Phase (40%) Trials

<10 Weeks CSR Turnaround Time

Reach out to us today and let our experts develop your clinical documentation while ensuring complete compliance. Email us at info@cmedresearch.com