Medical Writing
Our experienced and trained medical writers are responsible for preparing the study protocols in line with the sponsor's requirements and applicable regulatory guidance. The medical writing team also coordinates with the ethics committee for the necessary approvals
We provide
- Protocol development
- Protocol amendments
- Informed Consent Forms
- Case Report Form preparation
- Clinical study reports
- Bioanalytical sample analysis reports
- Method validation report
- Incurred sample re-analysis (ISR)
- Pharmacokinetic reports
- Biostatistical reports
- Final comprehensive report including safety reports
- Various types of documents necessary for a successful clinical trial
Our medical writing services are in full compliance with applicable regulatory requirements.
