Big Pharma Begins Mutually Recognizing GCP Training, Site Qualifications

Before each trial, sponsors usually ask investigators to complete good clinical practices (GCP) training, even if they have recently been assessed by other drugmakers or work for contract research organisations (CRO) and have considerable GCP experience.

To avoid this duplicate work Big Pharma members of industry group TransCelerate have launched a mutual recognition programme designed to establish common standards and establish skills requirements for investigators.

Katarina Hugeneck of Eli Lilly and project co-lead for TransCelerate told Outsourcing-pharma.com that: "The mutual recognition of GCP training for investigators and site staff has been implemented by most of the original ten member companies with the remaining companies having the updated training in place by the end of July​.”

She added that: “We expect the member companies to begin using the CV template and site profile form with sites during the second half of 2013​.” 

Pharma GCP training​

In early Q4 of 2013, the non-profit group is looking to offer other GCP training providers, such as professional organizations and vendors, to self-attest that their training meets the requirements set by TransCelerate. “This will increase the number of training solutions that may be mutually recognized by TransCelerate member companies​,” Hugeneck said. 

But the implementation of the qualification and training has required companies to begin its engagement earlier with those controlling these processes. 

“The challenge with the implementation of these three deliverables has been the internal ongoing stakeholder management within the member companies​,” Susan McHale of AstraZeneca, project co-lead for TransCelerate told us. 

“The changes required to the internal processes for the TransCelerate member companies have varied.  The site qualification and training team have learned this requires early engagement with the process owners so as the deliverables are finalized they can be incorporated into the internal processes and implemented quicker​.”    

CRO Involvement​ 

Although CROs may have to implement these new deliverables and shift their best practices, none of the individual companies directly contributed to their creation, though ACRO is engaging with TransCelerate.   

“ACRO has been engaged in an ongoing dialog with TransCelerate since the group was formed last year we are in the process of establishing a more formalized relationship​,” ACRO spokesman John Lewis told us.

“As a practical matter, ACRO members perform the vast majority of site training and qualification services. Similarly, ACRO members have been the leaders in promoting innovations such as risk-based monitoring​.” 

But for now, CROs are working on a case-by-case basis with their sponsor partners on the objectives. 

“A few member companies working with CROs shared the site qualification and training objectives and drafted solutions with the CROs and received informal feedback​,” Hugeneck said.

The relationships between pharma companies and CROs “vary so the participating member companies are each handling the interactions with their CROs by including them in their individual implementation plans​.”