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Our medical qualified personnel are able to offer a range of pharmacovigilance services to support your product development program.
Medical Monitoring for Clinical Trials
Datapharm can provide an Australian-registered medical practitioner to act as Medical Monitor during Clinical Trials. The function of the Medical Monitor is determined by agreement with the client and can include response to site questions about subject eligibility or other safety or medical issues arising at commencement or during the course of a clinical trial. The Medical Monitor may be required to be a member or to otherwise participate in DSMB meetings to discuss safety issues arising during a clinical trial.
What is the role of a Medical Monitor in Clinical Trials?
Although regulatory authorities do not mandate the requirement for a Medical Monitor and ICH GCP does not define this role, most Sponsors of clinical trials appoint a Medical Monitor with an MBBS (MD) to oversee the safety of trial subjects.
Depending on the project, the responsibilities of a Medical Monitor may include:
- Develop/review the Study Protocol
- Develop a Safety Management (Pharmacovigilance) Plan
- Develop a Medical Monitoring Plan
- Provide site support, including training on the study protocol and investigational procedures
- Provide Sponsor support, including staff training on the study protocol and therapeutic area
- Provide expert medical advice at Investigator Meetings/Site Initiation Meetings
- Determine/provide guidance on subject eligibility
- Assess significance of subjects’ out-of-range results
- Assess SAE reports
- Prepare case narratives for SAEs
- Support the Pharmacovigilance team, including review of medical coding
- Provide expert medical advice to Data Safety Monitoring Board (DSMB)/Safety Review Committee (SRC)
- Provide input on safety and other medical issues during the study
- Engage/network with Key Opinion Leaders (KOLs)
- Available for medical emergencies 24 hours a day, 7 days a week
Datapharm Australia is a full-service CRO that can provide an Australian-registered medical practitioner to act as the Medical Monitor for your clinical study. Datapharm Australia’s Medical Monitors have a depth of experience in both clinical practice and research.
Contact Datapharm Australia today on +61 2 9719 2800 for all your Medical Monitor needs!
- Patient safety always comes first in clinical trials.
- The Medical Monitor ensures oversight of all medical and safety aspects of a clinical study.
- The Medical Monitor is ideally a physician with both medical expertise and in-depth knowledge of the specific clinical study.
- The Medical Monitor supports each study site by a) answering study related questions so staff feel confident they are following the protocol as intended, and b) ensuring any medical issues with participants are dealt with safely and comprehensively.
- The Medical Monitor can assist the Sponsor throughout the study, from providing medical input on the protocol design to supporting the study conduct phase and providing guidance during the analysis and reporting of the study results.