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
- 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
