Boyds has an experienced team of pharmaceutical physicians who provide medical monitoring services across a wide range of studies and therapeutic modalities including advanced therapy medicinal products, oncology agents and orphan drugs.
Boyds act in line with GCP requirements, providing medical oversight at all phases of clinical trials. Medical monitoring is critical to protect the health and wellbeing of all clinical trial participants.
Our medical monitors spend time at the outset of a clinical study to understand the study and review and provide feedback on the study documents. This can include strategic oversight to optimise protocols for recruitment rates, patient satisfaction and retention. Medical monitors then provide all support required for the duration of the study through to study close out.
Over 20 years of involvement in contracting independent medical monitors has revealed that having an experienced, and subject-knowledgeable medical monitor can be pivotal to timely study success. The Medical Monitors at Boyds possess this unique combination of clinical and research experience to add significant value to both the investigative and sponsor teams.
Our medical monitors work with clients to carry out the following:
- Subject eligibility review
- AE/SAE review including case history clarification, answering queries arising from Investigators, facilitating CIOMS Narrative Review and sign-off
- Work alongside the study team, attending meetings as required
- Pharmacovigilance activities
- Study completion activities: Contributing to the writing of the clinical study report, review of all tables, listings and figures, culminating in sign off of the clinical study report as medical monitor