The medical writers at CTC have extensive clinical research knowledge and are skilled and efficient writers with a holistic perspective.
Protocol development at CTC is something very special. Experts from all departments, including, but not limited to, physicians, research nurses, statisticians, pharmacokinetic scientists, clinical research associates, clinical research managers and eCRF designers perform thorough protocol review to ensure that all aspects of the study conduct and subsequent analysis are considered prior to document finalisation.
Clinical study report writing is done in collaboration with representatives from the biometrics department, i.e. statistical programmers, statisticians and pharmacokinetic scientists to produce a top quality report accurately reflecting the study results.
The medical writing team also provides other writing services as outlined below:
- Clinical study protocols
- Clinical study reports (ICH-E3)
- Clinical investigational plans and reports (medical device)
- Development safety update reports (DSURs)
- Safety narratives
- Scientific articles
- Quality control