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TransCelerate initiates common criteria for investigator and site qualification and training

Friday, June 21, 2013

TransCelerate BioPharma, a nonprofit focused on advancing innovation in R&D, has reached several milestones in its initiative to realize efficiencies across clinical trial investigator and site qualification and training (“SQT”) efforts.

TransCelerate’s 16 biopharmaceutical members are implementing the first three: a set of minimum criteria for Good Clinical Practice (GCP) training content to enable members to mutually recognize training. This initiative uses a “TransCelerate GCP Training Certificate,” a standardized questionnaire for collecting generic information about study sites and a template for investigator Curriculum Vitae (CV).

Trial investigators and sites are required to complete questionnaires, forms and training courses to prepare for trial participation. Investigators and other site personnel who complete the TransCelerate common forms and training programs will not have to complete these prequalification tasks again. The TransCelerate GCP training standards and common forms reflect best practices available to these biopharmaceutical sponsors. This will improve the quality of information provided by each site and free up time and resources for investigators and sponsors, allowing for additional focus on study-specific and value-added activities that accelerate the delivery of therapies to patients.

TransCelerate expects a number of member companies will implement the mutual recognition of GCP training by July, 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, Ph.D., 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.

Now that the SQT initiative has achieved these near-term goals, the initiative will move into its second phase, in which member companies are continuing to realize efficiencies around pre-qualification efforts such as common oversight measures, training and forms and assessing the benefits of a common comprehensive framework for investigator/staff and site prequalification.

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