InCROM Achieve Accreditation
pharmafile | December 7, 2009 | News story | Research and Development |Â Â Â
According to the MHRA, a clinical research facility with standard accreditation can carry out all Phase I trials other than FIH (First in Human) trials with risk factors that would require review by the EAG (Expert Advisory Group); and a facility with supplementary accreditation can carry out trials with compounds at all levels of risk including those that require review of risk factors by the EAG.
The voluntary accreditation scheme was created as a reactive measure to the TGN1412 incident in March 2006, where six subjects became seriously ill and were admitted to intensive care. To be granted the accreditation means that the clinical facility has successfully passed on-site inspections of the facility, procedures and staff training and experience, and has met all the safety requirements specified by the MHRA.
ICRU started running its first clinical trials in November 2007 and has achieved accreditation status in just 16 months. It is the seventh unit to receive accreditation under the scheme.






