Medical Monitoring & Writing
Medical understanding of study data is a heart of a clinical research. Our Scientific and Medical Affairs team can provide both strategic and specific advice to sponsors, sites and project teams throughout the life of your study.
Prior to the study, we can provide:
- consultation on study design, including, but not limited to, patient selection, endpoint determination
- general feasibility assessment
- collaboration to develop a Medical Monitoring Plan
- therapeutic area/indication training of project team
During conducting of the study, we offer:
- medical review of study data: patients’ eligibility, review of critical study procedures values
- ongoing medical support for investigator sites during the study
- ongoing medical support for Monitors during the study
- assistance in pharmacovigilance activities
- review of subject safety-related data in database(s)
- medical coding of study data (MedDRA coding)
We also provide medical writing services for biotech, pharmaceutical, and medical devices industry. We have comprehensive understanding of various regulatory guidelines such as ICH-GCP, EMA guidelines, ISO 14155. Our dedicated team consisting of passionate professionals with qualifications in Medical, Pharmaceutical and other Life Science subjects has expertise across vast therapeutic areas. We have the know-how, skills, and readiness to help you develop clear, concise, and high-quality study protocols, ICFs, CRF plan, study reports and other documents tailored to your needs.