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Medical Monitoring

Medical Monitoring

It is a regulatory requirement that all clinical studies must have medical monitoring support when they are being conducted.

Boyds provides this support in relation to patient eligibility, adverse event advice and guidance and overall pharmacovigilance activities. Boyds is also able to provide CRA and clinical site management support if required.

The flexible approach depends upon client needs, whether assisting with an investigator’s brochure or protocol, preparing a study report and TFLs or working closely with clients in the ATMP and orphan disease areas.

“The sponsor should designate appropriately qualified medical personnel who will be readily available to advise on trial related medical questions or problems. If necessary, outside consultant(s) may be appointed for this purpose” (ICH E6 (Rev 1) Section 5.3).

Key Contact
Prof Alan Boyd
BSc, MB, ChB, FFPM
CEO
T +44 (0)1270 270010