PHILADELPHIA--(BUSINESS WIRE)--TransCelerate BioPharma Inc. announces the addition of several new initiatives to its expanded portfolio to help its membership and other stakeholders within the biopharmaceutical ecosystem streamline the development and delivery of innovative, new medicines to patients. As part of this growth, TransCelerate remains focused on its strategic priorities: Improving the patient and site experience, greater information sharing and process harmonization, and enhancing sponsor efficiencies.
“We have a major opportunity with these new projects to share experiences across our Member Companies and external partners and adapt processes and systems to fast-moving drug development trends and patient needs,” said TransCelerate CEO, Dalvir Gill, PhD. “The continued focus on our strategic priorities, roadmap for the future and our initiative portfolio reflects our ongoing commitment to improving the efficiency of drug development.”
Dr. Gill further noted, “By developing pragmatic solutions that leverage advancements in automation and analytics and focus on data quality, safety and integrity, we can drive meaningful change for patients, sites and other R&D stakeholders.”
Automation and Analytics
- Intelligent Automation of Drug Safety: Concentrating on identifying how intelligent automation technologies can be used to support execution of pharmacovigilance processes and limit errors commonly associated with manual data processing, TransCelerate will deliver recommendations that will initially help individual case adverse event identification, intake, processing and reporting.
- Advancing Safety Analytics: TransCelerate is developing materials around the application of interrogative methods towards various safety data sources. This could lead to further understanding of product safety profiles and support product development, as well as earlier identification of potential safety issues that could help minimize harm to patients.
Digital Data Flow: To enable the automation of data flow from
study protocol to study report, TransCelerate, in collaboration with
CDISC, is initiating new work that aims to define an integrated
digital process from beginning to the end. The Digital Data Flow
common data model will electronically link key elements of clinical
research from case report forms (CRFs), statistical analysis plans
(SAPs), and schedules of activities, to electronic data capture (EDC)
systems, etc. The benefits of automating the data flow are a
significant reduction in operating time and costs, as well as
increased data quality.
“CDISC and TransCelerate have enjoyed a productive, working relationship for some time now,” noted David R. Bobbitt, President and CEO of CDISC. “CDISC is committed to this innovative project as we work together toward more consistent implementation of data standards to improve the quality, efficiency and cost effectiveness of clinical research processes from beginning to end.”
Data Quality and Integrity
- Common Registry Data: As highlighted through TransCelerate’s patient-centered initiatives, quality and availability of submitted clinical research data remains a problem. These challenges impact patients, caregivers and health care providers’ ability to consider clinical research as an option. TransCelerate has undertaken this initiative to deliver recommendations on authoring and procedural best practices for registry submissions in order to address the National Institute of Health’s request to the industry to resolve data quality issues with public clinical research registries, and as a precursor to taking more significant steps to make clinicaltrials.gov more user-friendly and patient-centric.
- Common Statistical Analysis Plan (SAP): A common SAP template will provide a model layout and content for SAP documentation and would directly link to TransCelerate’s Common Protocol Template (CPT). The use of a Common SAP Template enables content reuse that could help accelerate the review of SAP’s by health authorities and reduce the number of data entry errors.
- Data Monitoring Committee (DMC): To address limitations of experienced and/or qualified DMC members, TransCelerate will develop a framework that facilitates enhancing the skillset and increasing the number and pool of people qualified to serve on a DMC.
- Protocol Deviations: To foster site and sponsor efficiencies for collection and analysis of protocol deviations, TransCelerate will work with health authorities to create a flexible best practice toolkit and framework for the collection, management and reporting of protocol deviations, directly tackling the confusion created by the global reporting requirements and the potential resulting safety concerns.
Commenting on the expanded portfolio, Elliott Levy, MD, Senior Vice President, Global Development, at Amgen, and Chair of the Board for TransCelerate, stated, “Following a landscape assessment and a rigorous ideation process with our Members, we’ve been able to pinpoint efforts that could address the complex and critical challenges impacting the delivery of innovative therapies to patients.”
Dr. Levy continued, “In a short amount of time, just five years since its inception, TransCelerate has been effective in driving major impact to multiple drug development stakeholders. To date, TransCelerate has successfully delivered over 30 solutions across 20 initiatives. Each solution further simplifying processes and giving way to improvements that address some of the major pain points in research and development.”
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. The vast majority of TransCelerate solutions are publicly available. The member companies of TransCelerate are AbbVie, Allergan, Inc., Amgen, Inc., Astellas Pharma Inc., AstraZeneca, Boehringer Ingelheim, Bristol-Myers Squibb, Eli Lilly and Company, EMD Serono, Inc. (a subsidiary of Merck KGaA, Darmstadt, Germany), GlaxoSmithKline, Johnson & Johnson, Merck & Co., Inc., Novartis, Novo Nordisk, Pfizer, the Roche Group, Sanofi, 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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