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 practise of integrated review and our medical writing team is fully integrated with the clinical operation, data management and biostatistics to address the function specific requirement. We also get inputs from practising physicians and lab scientists to add medical and scientific synergy in the document. Our team proficiently handles the medical writing activities of drugs, biologics, 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 specialise in managing the following medical writing services from preparation phase to post marketing phase:
Preparation of Clinical Study Protocol and Investigator Brochure
Preparation of Informed Consent Forms, Dairy Cards and Study Assessment Questionnaires
Preparation of Medical Monitoring Plan, Safety Management Plan, Study Specific Medical Monitoring and Safety Reporting Processes.
Preparation of Study Procedure Manuals, Study Updates and Newsletters
Preparation of Clinical Study Reports
Preparation of Abstracts, Manuscripts , Case Studies, Standard Operating Procedures and Periodic Safety Update Reports (PSUR)
Collection and Analysis of Key Opinion Leader's Inputs for Study Design