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

PHILADELPHIA, June 20, 2013 /PRNewswire/ -- 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.

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