CTC offers comprehensive medical expertise support by our Medical Monitors, our in-house Physicians with wide experience in various therapeutic areas and the pharmaceutical industry. The Medical Monitor works on behalf of you as a sponsor, either as your sole medical expert or in close collaboration with your medical representative.
The Medical Monitor can assist you in a broad range of services such as providing an overall medical responsibility, oversight and support for Investigators as well as qualified input on regulatory documentation such as clinical study protocols/clinical investigation plans and reports with focus on safety, as well as the Reference Safety Information (RSI) section of Investigator’s Brochures (IB). During your trial our Medical Monitor can also perform the Sponsor oversight surveillance of generated safety data that is required by authorities. Furthermore, risk assessment and risk mitigation strategies are also central to the role and the Medical Monitor can take an active part in safety review committees.
- Establish a medical monitoring plan
- Medical review of clinical study protocol/clinical investigation plan, report and RSI section of Investigator’s Brochure
- Primary contact for Investigators regarding safety- and protocol- related questions
- Continuous medical surveillance of safety data during the clinical study/investigation
- Regular safety data meetings to comply with Sponsor oversight
- Availability business hours or 24/7 depending on the specific needs of the trial
- Participation in internal Safety Review Committees (iSRC)
- Participation in independent Data Monitoring Committees (DMC)