Medical Writing
Our team recognises the importance of scientific writing and creates documents that are both concise and substantive. Our medical affairs department is made up of physicians, scientific writers, and safety experts. We also have a team of practising physicians serving as external consultants and subject matter experts to provide input on major documents such as protocols, safety management plans, and recruitment strategies.
The following Medical Writing Services are our area of expertise from planning of Clinical trials to marketing authorization.
- Drafting and finalization of ICH GCP compliant Clinical trial Protocol, Investigator Brochure (IB).
- Drafting and finalization of Informed Consent Forms (ICFs), Patient Diary Cards (PDC) and Study Specific Questionnaires.
- Drafting and finalization of Clinical Study Reports in consultation with different departments.
- Literature Reviews.
- Publication Planning.
To address function-specific requirements, we use comprehensive review and our medical writing team is fully integrated with the clinical operations, data management, and biostatistics departments. To add medical and scientific alignment to the document, we also solicit input from practising physicians and lab scientists. All of our deliverables are subjected to a thorough review by our quality assurance department to ensure accurate representation and regulatory compliance.