Medical affairs is a comprehensive work that covers multiple key areas, aimed at ensuring the scientific, compliant, and ethical nature of medical research, as well as the safety and effectiveness of medical products. At present, medical affairs mainly consist of two parts: medical science and medical supervision.

Medical Science

The medical science team includes medical writers and clinical research physicians. The team members all have rich clinical work and pharmaceutical industry experience, familiar with domestic and foreign regulations and GCP, and the core backbone has more than 10 years of clinical development experience in multinational pharmaceutical companies or large domestic pharmaceutical companies.

Service Content

The medical science team provides services covering the entire process of clinical development of drugs and medical devices, including but not limited to:

Consultation and strategy development for Phase I-III clinical research and development pathways;

● Design clinical research protocols before or after market launch (including IIT, RWS, and post market commitment studies), as well as write investigator manuals, informed consent forms, and clinical research reports;

● Review of case report forms, research medical records, and medical support during the trial period;

● Preparation and writing of IND and NDA related medical content for registration application materials.

Medical Supervision

The GCP ClinPlus Medical Monitoring Team includes a Medical Monitoring Manager and expert consultants. The team members all have rich clinical work and industry experience, and the core backbone has more than 10 years of relevant industry experience.

Service Content

● Development and maintenance of medical monitoring plan, medical training, medical consultation, medical review

● The service areas involved include but are not limited to: tumors (solid tumors, blood tumors), endocrine, respiratory, digestive, cardiovascular, neurology, rheumatology and immunology, ophthalmology, skin, instruments, etc

● Involving different clinical stages: Phase I-IV clinical studies, IIT studies, BE studies, etc

Medical Writing Service Content

Service Tenet

The quality of clinical research comes from design. Based on sufficient medical background and strong research literacy, the GCP ClinPlus Medical Science team assists enterprises in clinical research and development of drugs and medical devices. Ensure sufficient identification of common issues with rich project experience, ensure specific project analysis with sufficient medical considerations, and design and write high-quality clinical research plans; Closely integrate statistical considerations and clinical operational project implementation during the clinical research design phase to ensure an organic balance between the scientific and implementable nature of the research plan; To accelerate research and development, reduce costs, and increase efficiency for enterprises.