Boyds has an experienced team of pharmaceutical physicians who offer medical monitoring support across a wide range of studies including advanced therapies, cell and gene therapies and orphan drugs.
It is a regulatory requirement that all clinical studies have medical monitoring support when they are being conducted.
Our medical monitors spend time at the outset of a clinical study to understand the study and analyse the study documents. They are then available for the duration of the study to provide all support required for the duration of the study through to study close out.
Our medical monitors work with clients to carry out the following:
- Study set-up phase – review and familiarisation of the study protocol and management plan, attending study team set-up meetings as required
- Study recruitment eligibility
- AE/SAE CIOMS Narrative Review and sign-off
- Work alongside the study team attending meetings as appropriate
- Adverse event advice and guidance
- Pharmacovigilance activities
- On completion of the study, review of all tables, listings and figures
- Sign off the clinical study report as medical monitor