Our team understands the importance of scientific writing and they will produce very concise and substantive documents. Our medical affairs department comprises of physician, scientific writers and safety experts. We also have a team of practicing physicians as external consultants on subject matter to provide inputs on major documents like protocol, safety management plan and recruitment strategies.
We are following the practice of integrated review and our medical writing team is fully integrated with the clinical operation, data management and bio-statistics to address the function specific requirement. We also get inputs from practicing physicians and lab scientists to add medical and scientific synergy in the document. Our team proficiently handles the medical writing activities of drugs, biologic, and medical devices across all clinical phases. All of our deliverables undergo a rigorous quality assurance review to ensure accurate representation and compliance with regulatory requirement.
We specialize in managing the following medical writing services from preparation phase to post marketing phase:
1. Preparation of Clinical Study Protocol and Investigator Brochure
2. Preparation of Informed Consent Forms, Dairy Cards and Study Assessment Questionnaires
3. Preparation of Medical Monitoring Plan, Safety Management Plan, Study Specific Medical Monitoring and Safety Reporting Processes.
4. Medical Monitoring
5. Preparation of Study Procedure Manuals, Study Updates and Newsletters
6. Preparation of Clinical Study Reports
7. Preparation of Abstracts, Manuscripts , Case Studies, Standard Operating Procedures and Periodic Safety Update Reports (PSUR)
8. Collection and Analysis of Key Opinion Leader’s Inputs for Study Design