Confidence specializes in the comprehensive management of client-sponsored clinical trials. Our Medical Monitoring Services, a cornerstone of our approach, provide continous medical supervision of all study procedures, activities and issues that may arise during a study to ensure the safety of participants and the integrity of research data.
Our team of medical experts at Confidence is engaged throughout the entire clinical trial lifecycle. From feasibility assessments and site selection to trial initiation, execution, and activation, we collaborate closely with investigators from the very beginning. This collaborative approach includes comprehensive study protocol training of site staff, proactive identification and resolution of challenges, and gathering feedback regarding the protocol design, entry criteria and other crucial points to optimize the clinical trial’s design efficiency. It also involves overseeing the study conduct during enrolment, treatment period and follow-up in collaboration with the operational team.
Confidence’s Medical Monitoring team consists of medical doctors with board certification in different therapeutic areas, experience as practising physicians and clinical researchers, and solid industry experience in performing medical monitoring and safety activities in a wide spectrum of therapeutic areas studies such as cardiovascular, metabolic and endocrine, haematology and oncology, infectious diseases, neurology and psychiatry, nephrology, gastroenterology, ophthalmology, autoimmune diseases, rare diseases, and device studies.
Confidence Medical Monitors are highly skilled in the evaluation of the study progress, making medical decisions with regard to the study protocol compliance, and provision of medical consultancy to investigators, project team members, study sponsors, and vendors.
Confidence’s comprehensive range of Medical Monitoring Services include but are not limited to:
- Medical review of essential study documents and amendments
- Set up of medical monitoring processes, including development of relevant plans and forms
- Trainings on protocol and/or therapeutic areas
- Medical safety
- Medical consultancy
- Eligibility reviews
- Clinical trial database reviews
- Data and Safety Monitoring Committees (DSMB) support