News

26th March 2011

Simbec – Spring 2011 Newsletter

MediWales Member, Simbec, Supplementary Accredited for Phase I, is highly experienced in the development of novel therapeutics and focuses on the early clinical development of new medicinals. They have over 35 years’ experience of continuous service in Phase I-IIa clinical research and bioanalytical research.  Understanding the need to reduce costs and the time it takes to get drugs to market, they have optimised their services for faster recruitment and efficient study completion.  All services are on one site including a 58 bed clinic with 6 wards, 5 consultation rooms, volunteer recruitment, bioanalytical laboratory, central laboratory, project management, data management, statistics, quality assurance and an MIA(IMP) compliant pharmacy.

 
Simbec has first hand experience of guiding a monoclonal antibody through the process in the UK for the First-in-Human of a "higher risk" new chemical entity. This process involves an Expert Advisory Group (EAG), the Commission on Human Medicines (CHM), MHRA and Ethics Committees.
 
Simbec is also the first UK CRO to receive renewal of its Supplementary Accreditation under the MHRA’s Phase 1 accreditation scheme.
 
To read more on their current activities, you can peruse their latest Sping 2001 newsletter, Analysis