PHILADELPHIA--(BUSINESS WIRE)--TransCelerate BioPharma Inc. today announced that its Site Qualification and Training (SQT) Initiative has reached its target outcomes by addressing pain points voiced by investigators and sites that were selected at the formation of TransCelerate in 2012. The quality and integrity of the SQT Initiative solutions will be maintained by TransCelerate and are available for use and download on our website by investigators, sites and clinical research organizations. Select deliverables will be assumed by outside organizations, as needed. In addition, the Initiative is introducing two new industry solutions: 11 informational programs targeted to investigators and their staff that are less experienced in conducting clinical research and an online framework for sponsors to mutually recognize electronic data capture (EDC) system training taken by investigator site personnel.
Commenting on the SQT Initiative’s achievement, Katarina Hugeneck, SQT Initiative Leader and Manager of Global Study Training at Eli Lilly and Company, noted, “Traditionally, clinical trial investigators are required to complete multiple forms and trainings for several companies for different trials. We’ve developed tools and resources to improve the qualification and training process, while freeing up time and resources for investigators and sponsors alike, to focus on study-specific and value-added activities.”
TransCelerate's CEO, Dalvir Gill, PhD, states, "I want to thank Katarina and the entire SQT team for their efforts. As one of our first Initiatives, we outlined our mission early on - establishing minimum criteria for mutual recognition of GCP training, a self-attestation process for external GCP training providers, common forms to collect generic site information, and informational programs for investigator site personnel. We’ve achieved that, and much more.”
“As initiatives like SQT move into an implementation / realization phase, we will continue to learn from experience, and can shift focus to other priority areas that have the potential to benefit from our unique collaboration.”
TransCelerate has also introduced 11 Informational Programs to provide less proficient principal investigators, sub investigators, site managers, study and regulatory coordinators with educational content at the start and during the conduct of a clinical research study, and used as a reference for remediation when necessary. The TransCelerate SQT Initiative developed the Informational Programs to cover broad topics such as responsibilities around adverse event reporting and informed consent, overview of activities for IRB/IECs, and tips for monitoring and auditing. These tutorials were created in accordance with the ICH Guideline for Good Clinical Practice: Consolidated Guidance (E6) and can be accessed through the TransCelerate website here.
The content within the Informational Programs was developed with the collective knowledge and expertise of TransCelerate Member Company personnel with contributions from sites staff representatives through the Society for Clinical Research Sites (SCRS) Site Advocacy Group. In addition, TransCelerate has selected SCRS to maintain the Informational Programs as the SQT Initiative eases its efforts. The Informational Programs will be available on the SCRS website by the summer of 2016.
“SCRS is pleased to have collaborated with TransCelerate in the development of the Informational Programs. This valuable information for sites will provide new perspectives and lessons to further our goal of supporting site sustainability. We look forward to working with TransCelerate on other opportunities that lessen the burden on sites and improves on inefficiencies during a clinical study,” said Christine Pierre, President, Society for Clinical Research Sites.
The SQT Initiative also announced the creation of an online framework to mutually recognize completed, non-protocol specific EDC system training by multiple sponsors, reducing an unnecessary trial burden on investigator site staff. This effort builds off the success of TransCelerate’s mutual recognition of Good Clinical Practice (GCP) training program which has issued over one hundred thousand certificates to date, making it unnecessary for investigator site personnel to train separately for participating TransCelerate Member Companies. With this framework available, if you are a sponsor or vendor that provides EDC system training, you can visit the TransCelerate website, submit an electronic confirmation form verifying details of your EDC system training, and provide a sample of the training providers certificate, if requested.
For more information about the EDC system training framework, visit the FAQs page on the TransCelerate website.
About TransCelerate BioPharma, Inc.
TransCelerate BioPharma Inc. is a non-profit organization dedicated to improving the health of people around the world by simplifying and accelerating the research and development (R&D) of innovative new therapies. The organizations' mission is to collaborate across the global biopharmaceutical R&D community to identify, prioritize, design and facilitate implementation of solutions designed to drive the efficient, effective and high quality delivery of new medicines. TransCelerate evolved from conversations at various forums for executive R&D leadership to discuss current issues facing the industry, and examine solutions for addressing common challenges. The founding member companies are AbbVie, AstraZeneca, Boehringer Ingelheim, Bristol-Myers Squibb, Eli Lilly and Company, GlaxoSmithKline, Johnson & Johnson, Pfizer, the Roche Group, and Sanofi. Additional members that have joined since the inception of TransCelerate include Allergan, Inc., Amgen, Astellas Pharma Inc., EMD Serono, Inc. (a subsidiary of Merck KGaA, Darmstadt, Germany), Merck & Co., Inc., Novo Nordisk, Shionogi & Co., Ltd. and UCB.
Membership in TransCelerate is open to pharmaceutical and biotechnology companies with Research & Development operations. Executive offices are located in Philadelphia, PA. For more information, please visit http://www.transceleratebiopharmainc.com.
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