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Medical Writing

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.

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State of the art facilities. World class leaders. Innovative scientific expertise

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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Complete the form to schedule a Discovery Call with one of our medical experts to learn how BioPharma Services can be your trusted clinical trial partner.

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