TransCelerate BioPharma Inc. Takes Steps Toward Common Clinical Trial Site Qualification & Training

TransCelerate BioPharma Inc. ("TransCelerate") today announced that it has reached several important milestones in its initiative to realize efficiencies across clinical trial investigator and site qualification and training ("SQT") efforts. In order to address areas of discord voiced by investigators and sites, TransCelerate's sixteen biopharmaceutical company members are implementing the first three deliverables of the SQT initiative: a set of minimum criteria for Good Clinical Practice (GCP) training content that will enable member companies to mutually recognize one another's training. This initiative includes the use of a common "TransCelerate GCP Training Certificate"; a standardized questionnaire, or "Site Profile Form," for collecting generic information about study sites; and a template for investigator Curriculum Vitae (CV).

Traditionally, clinical trial investigators and sites are required to complete – for each company, and often, per trial – questionnaires, forms and similar training courses to prepare for participation in trials. Investigators and other site personnel who complete the TransCelerate common forms and training programs – which meet the minimum criteria and/or produce a TransCelerate GCP Training Certificate – will not have to complete these prequalification tasks again for participating companies. The TransCelerate GCP training standards and common forms reflect best practices available to these biopharmaceutical sponsors. Ultimately, this will improve the quality of information provided by each site, and free up time and resources for investigators and sponsors alike, allowing for additional focus on study-specific and value-added activities that accelerate the delivery of important therapies to patients.

TransCelerate expects 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. We look forward to continuing our work with TransCelerate to find other pre-competitive opportunities that will aid the sites, and thereby the industry. It is a true milestone that industry is listening to the sites and taking action like this."

Now that the SQT initiative has achieved these near-term goals, the initiative will move into its second phase, where 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.

A list of TransCelerate member companies and their acceptable minimum criteria for GCP training, as well as common forms for investigator CVs and site-specific profile information, can be found at the link under "Site Qualification and Training" here.