Medical Writing
Quality Assured Medical Professionals
With a combined 30 years experience, BioPharma’s Medical Writing team provides a full suite of writing services, having completed study documents for over 2600 clinical trials. This expert team collaborates with all departments (Medical, Clinical, Pharmacy, Regulatory Affairs, Biostatistics, Data Management, Project Management, Quality Assurance, and Bioanalysis) and is in close contact with review boards to ensure timely study reporting.
With the aim of providing clear communication between subjects, sites, sponsors and regulatory agencies, the Medical Writing team combine medicine, science, and technical writing to produce the following documentation:
Clinical Trial & Program Documentation
- Protocol Synopsis, Protocols and Amendments
- Informed Consent Forms
- Clinical Study Reports (CSRs)
- Safety reports
- Pharmacokinetic reports
- Biostatistical reports
- Bioanalytical reports
Regulatory Submission Documents
- Applications in eCTD format including CTA, IND & NDA
- Agency response review
- Regulatory Briefing documents for Agency meetings
- Meeting with Regulatory Agencies
Ethical Review Board Submission
- Submission to Ethical review board
- Meeting with Ethical review board
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