- Develop the medical monitoring plan (MMP)
- Provide medical review of the protocol and CSR
- Provide medical training (including MMP, protocol, related therapeutic area, etc.); subject eligibility review; protocol deviations review; medical consultation; and after-hours medical coverage (24/7)
- Provide medical review of CRF, medical review for clinical data and medical support for data cleaning
*As of Q1 2020
Commitment to high quality in clinical trials
- Regularly develop and update SOP for medical monitoring,
- Strictly manage the whole process of medical monitoring during the conduct of the clinical trials
- Initiation of clinical trials: medical review of protocol and develop MMP
- Conduction of clinical trials: implement the medical monitoring activities, such as subject eligibility review; protocol deviations review; medical consultation, medical review on clinical data and medical support for data cleaning etc.
- Comprehensive and solid training program and team management.
Specialization and team stability
- All the team members have master’s degree or above in clinical medicine, with rich experience in clinical practice and clinical trials.
- Above 50% members have more than 2-year medical monitoring experience in clinical trials. Above 20% members have more than 5-year experience in the conduction of clinical trials.
- The retention rate of core team members is 100%. The turnover rate of team members is less than 5%.
Assurance for the implementation of multi-regional clinical trials
- Take the lead in completing the medical monitoring SOP integration of Tigermed and its subsidiaries in US/Europe/South Korea. which gets ready to globally conduct the medical monitoring business in Europe, US and Asia-pacific regions and contribute to the development of Tigermed globalization strategy in clinical trials
*As of Q1 2020
- Scope: PhaseⅠ- Ⅳ clinical trials
- Therapeutic area: oncology, endocrinology, respiratory medicine, rheumatology; cardiology, infectious disease, anesthesiology, hematology, dermatology, ophthalmology, etc.
- Previous experience: take medical leadership and management in more than 100 clinical trials, including more than 40 projects in the field of oncology, and more than 60 projects in the other therapeutic areas