Cancer Research UK Clinical Trials Support

The Cancer Research UK Formulation Unit supports and maintains the supply of materials to the clinical trial centres participating in trials performed by Cancer Research UK. The Unit has a number of staff dedicated to Quality Assurance and a member of staff dedicated to maintaining the flow of documentation to and from the regulatory department of Cancer Research UK and the MHRA. Several of the senior academic and research staff perform GMP audits of external production facilities both within and outwith the UK and Europe.

The Units also acts as a storage and distribution facility for clinical trial material produced by other manufacturing sites for Cancer Research UK clinical trials. The Unit has performed (and published, below) controlled temperature shipping validation studies. The Unit often has to relabel clinical trial supplies following date extension, which is a manufacturing step under GMP. The Unit is activity involved in the shelf life extension of clinical trials products, which is a substantial amendment requiring formal regulatory approval under the EU clinical trials directive.

Elliott MA, Halbert GW, (2005) Maintaining the cold chain shipping environment for Phase I clinical trial distribution, International Journal of Pharmaceutics, 299 (1-2): 49-54.