We prepare quality medical writing deliverables for you with the right key messages for regulatory documents. Our medical writing team has expert medical writers who are supported by clinicians.
Our team has considerable experience writing clinical study reports. We integrate the medical and statistical results in a way that meet the needs of clients’ and regulators. Our CSR template is fully compliant with ICH guidelines. We succinctly discuss the clinical relevance of the results and highlight any unexpected findings.
Our Medical Writing Services:
- Clinical Study Reports
- Developmental Safety Update Reports
- Periodic Benefit-Risk Evaluation Reports
- Risk Evaluation and Mitigation Strategy Documents including Medication Guides
- European Union Risk Management Plans
- Risk Minimisation measures