Medical Writing

Zi Diligence Medical Writing team provides a full suite of writing services having completed study documents for over 140 studies. 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 combines medicine, science, and technical writing to produce the following documentation:

Clinical Trial and Program Documentation

• Protocol Synopsis,
• Protocols and
• Amendments
• Informed Consent Forms
• Bioequivalence Study Reports
• Safety reports
• Pharmacokinetic reports
• Biostatistical reports
• Bioanalytical reports

Ethical Review Board Submission

• Submission to Ethical Review Board
• Meeting with Ethical Review Board