Medical Writing

Our medical writing team expertise to write clinical trial documents and marketing applications to support your clinical trial

Medical writers are critical to the communication process of outlining the goals, strategies, analysis and medical understanding of a clinical trial/program to patients, sites, sponsors and regulatory agencies. Orcigenix’s regulatory and medical writers team are lucid and to the point in every step of the process of preparing clinical documents including protocols, clinical study reports (CSRs), and Investigator’s Brochures.

Medical writing for clinical trials & regulatory submissions

Orcigenix provides medical writing support to the operational departments including Biostatistics, Medical Affairs, Quality Assurance, Regulatory and Clinical Operations beginning with early-stage development through marketing application and to post approval. Orcigenix provides rapid turnaround to meet deadlines efficiently.

Our medical writing team supports the development of the following types of documentation:

Clinical Trial & Program Documentation

• Protocol Synopsis, Protocols and Amendments
• Informed Consent Forms
• Clinical Study Reports (CSRs)
• Clinical Development Plans
• Investigator Brochure
• Patient Information Leaflets
• Annual/ Aggregate reports
• Periodic safety update reports (PSURs)
• Patient Safety Narratives

Regulatory Publishing

• Regulatory agency submissions
• Regulatory writing
• Clinical & Non-Clinical Summaries (Module 2)
• Responses to Agency reviewers
• Risk Management Plans