Medical monitors in clinical trials: the linchpin between patients and sponsors

Medical monitoring is an essential component of clinical trials: ensuring participant safety and data integrity. This medical oversight is often thought of as part of the sponsor team, our independent medical monitors (MM) at Boyds work on behalf of the sponsor, providing oversight across multiple study sites or multiple separate clinical trials.

Independent medical monitors.Boyds has a long history of providing independent medical monitors, founded on a broad scope of expertise, frequently in collaboration with internal clinical operations and strategic activities. Maximum benefit can be derived from collaborative involvement early on during study set up processes by providing expert medical input. This is often combined with expert strategic consulting on aspects such as study design and feasibility to optimise study power and balance the burden of safety and efficacy assessments to promote patient centricity. Integrating processes can help to minimise the risk of designing a study which is difficult to recruit for, or unlikely to be acceptable to patients. Medical monitors become an integral part of the study team, attending or conducting site initiation visits, providing an excellent opportunity to both review facilities and get to know the investigator team.

During the study, medical monitors are contracted to be available 24 hours a day, 7 days a week for emergency contact. This includes the provision of a backup monitor in case of leave. This enables monitors to rapidly review any incoming questions specifically relating to participant safety or medical aspects including eligibility and reviewing safety issues as they emerge. A bespoke approach and regular sponsor interaction enables medical monitors to integrate both within the sponsor team and investigative sites, complimenting work undertaken by clinical research associates whilst assuring that patient safety is central to clinical trial conduct.

Medical monitor expertise.Medical monitors must be medically trained as doctors, holding an active licence with the General Medical Council (GMC), with training and experience in clinical research and the pharmaceutical industry. The medical monitors within Boyds are highly experienced, with many holding additional post-graduate qualifications not only within pharmaceutical medicine, but also in other medical specialities. This clinical expertise enables us to match individual physicians to specific clients by their areas of expertise, from human challenge and early phase studies to paediatrics, vaccines and oncology.

Over 20 years involvement in contracting independent medical monitors has revealed that having an experienced, and subject knowledgeable medical monitor can be pivotal to timely study success. Medical monitors and Boyds possess a unique combination of clinical and research experience to add significant value to both the investigative and sponsor teams.