Clinical and Medical Affairs

Boyds was established 20 years ago and has a proven track record in strategic drug development. We provide clinical and medical support for all stages of drug development. Dr Karen Mullen, Chief Medical Officer at Boyds, leads a team of specialized pharmaceutical physicians who have extensive expertise in the clinical development of pharmaceutical and biological products across all therapy areas.

An overview of Boyds’ Clinical and Medical services:

• Interim Chief Medical Officer: Ideal for early-stage companies or to meet increased medical demand in larger, more established companies.
• Clinical development strategy, study design and protocol writing.
• Medical strategy: Including dose selection, indication selection and identifying suitable patient populations.
• Medical monitoring across early phase to late phase studies providing 24-hour cover.
• Clinical trial management, interim clinical study managers, all aspects of study start up including site selection, provision of CRAs and clinical monitoring.
• Medical Writing: proctocols, and study docments (IB, PSURs, CSRs), regulatory documents, (INDS, Orphan drug, scientific advice) and publication manuscripts.
• Medical input into regulatory strategy and documents, such as pre-IND meetings, scientific advice safety issues.

In addition to the above, Boyds has extensive product development and regulatory experience and expertise in NCEs, drug delivery devices and biologic products.