Medical Monitoring
Clinmark’s highly experienced medical monitors cover most key therapeutic areas. Gained knowledge and experience allows us to apply innovative approach to clinical trials. Prior to the study our team provides consultation on study design, patient selection, endpoint issues, feasibility and site selection. Our medical monitor can also support you with comprehensive medical plan development. Besides conducting clinical trials Clinmark offers medical review of eligibility, assists pharmacovigilance activities, support monitors in medical issues.
Medical Writing
Clinmark provides medical writing services for biotech, pharmaceutical, and medical devices companies. We have comprehensive understanding of various regulatory guidelines such as ICH-GCP, EMA guidelines, ISO 14155. Our dedicated team consisting of passionate professionals has expertise across vast therapeutic areas and qualifications in Medical, Pharmaceutical and other Life Science subjects. Our know-how, skills, and readiness to help will allow to develop clear, concise, and high-quality study protocols, ICFs, study reports and other documents tailored to your needs. We are a member of European Medical Writers Association.
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, the sites and project teams throughout the life of the 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 the study conduct 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 a 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.
