Building your success with strategic insight, knowledge, and experience
Medical monitors are physicians who get to know your project intimately as they are often involved from the initial study design through to the study close-out. From strategic guidance to resolving detailed issues, TFS HealthScience medical monitoring experts have robust academic, clinical, and product development experience and are key to successful study execution.
Medical monitoring services
Protocol Design and Review
- Study design input
- Endpoint review and recommendation
- Medical review for the protocol writing
- Medical informatics and feasibility support
Site and Site Management Team Interaction
- Supporting sites with protocol-related questions
- Communicate with the sponsor and the medical team
- 24/7 availability to resolve urgent matters
- Keeping Q&A log
Medical Data Review
- Ongoing review of data quality and integrity
- Regular reviews of listings, patient profiles and data graphics
Study Reports Review
- Overseeing narratives and clinical study reports
- Supervising aggregate study reports
Medical Safety Monitoring
- Lab and ECG alert review
- Contributing to the safety committee, DSMB, IDMC meetings
- Patient safety monitoring
- Events of Special Interest and Serious Adverse Events review
- Signal detection
Critical role, core knowledge
Working closely with the site, the project team, and the client, the medical monitor is the expert point-of-contact for each. They oversee the integrity of the trial.
Medical monitors are responsible for assuring that the rights and well-being of human subjects are protected, that the trial data is compliant with the approved protocol, and that Good Clinical Practice (GCP) and other regulatory requirements are fulfilled. Then, once the study is underway, they assure the quality of the reported trial data: that it is accurate, complete, and verifiable.
Strategies driven by results
TFS medical monitors have provided senior oversight for medicinal product and device trials, phases I-IV for more than 20 large studies in the last five years covering 800 sites and 8,000 patients, including studies in the following key therapeutic areas in which TFS maintains in-house medical monitoring expertise globally:
Dermatology, Immunology and Inflammatory Diseases
Why is it important to include a medical monitor in your clinical trial?
Medical monitors add specialist knowledge to the study, collaborating with the team and stakeholders, clearly understanding the objectives of the protocol and keeping the focus on the trial success.
Partnership based on mutual trust, reliability and clinical research excellence
As a mid-size CRO we are big enough to give you global reach yet still uphold the values of personal relationships and direct communication. When we work with our customers, we become one team—we could be working with you.Contact Us