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TransCelerate BioPharma Inc. Takes Steps Toward Common Clinical Trial Site Qualification & Training
Date:6/20/2013

pects that a number of member companies will implement the mutual recognition of GCP training by July 2013, and the Site Profile Form and CV template will be implemented into internal processes throughout the second half of 2013. This will continue as new member companies join TransCelerate.

"Disparate and redundant GCP training, and collection of non-study specific information, are pain points for investigators and sites, as well as biopharmaceutical companies," said Dalvir Gill, PhD, Chief Executive Officer of TransCelerate. "Since every company has to address these issues when conducting clinical trials, the benefits that will come from the work we're doing will provide no competitive advantage for any one company, but rather a collective advantage for all, including our sites and investigators. These pre-competitive, collaborative approaches are what drive TransCelerate's efforts."

Prior to the establishment of TransCelerate, individual member companies occasionally had recognized external site prequalification assessments (e.g., externally provided GCP training courses). The establishment of these TransCelerate initiatives will not invalidate any company-specific recognition decisions. In the future, external providers of GCP training will be able to self-attest to meeting the minimum criteria identified by TransCelerate.

"The industry is long overdue for a standardized framework for qualification of clinical sites like what TransCelerate is trying to bring forth. These initial deliverables of the SQT initiative are the first steps in the right direction," said Christine Pierre, President, Society for Clinical Research Sites. "SCRS is thrilled with this meaningful change for clinical trial sites – the efficiencies that will be gained by these seemingly 'small' adjustments will free up time that has been wasted providing redundant and relative information to the same companies.
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SOURCE TransCelerate BioPharma Inc.
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