Italian CRO receives early phase accreditation in EUCROF pilot
The EUCROF Quality Mark scheme is a pilot programme that consists of an independent audit process which examines twelve areas of operations in early phase units, including patient safety, regulatory compliance and organizational quality.
CRC - an early phase focused subsidiary of Cromsource - was audited in this pilot study and yesterday the firm announced it was the first company to be successfully accredited by the EUCROF.
However, Philippe Van Der Hofstadt, Co-chair of EUCROF Early Phase Working Group, told Outsourcing-Pharma.com “this new accreditation scheme is still being worked on and the first accreditation is part of our pilot study to challenge our draft scheme.”
He continued: “The ultimate goal is to auto-control the early phase units and to standardize the level of minimal quality throughout Europe.”
Once the pilot scheme is completed, the full scheme will be proposed to EUCROF’s Board, he told us, before being discussed with both the authorities and pharma companies.
According to CRC Medical Director, Dr. Stefano Milleri, the firm is “sure that this Quality Mark will also provide a useful benchmark for future clients,” due to being “assured instantly from an independent expert source that our work here at CRC is consistent with the highest quality and safety standards.”
The trial coincides with recent reports that some CROs are seeing an uptick in early phase clinical work after almost two years of lagging.
