Navigation Links
TransCelerate BioPharma Inc. Reveals Collaborative Methodology for Risk-Based Monitoring of Clinical Trials

PHILADELPHIA, June 3, 2013 /PRNewswire/ -- TransCelerate BioPharma Inc. ("TransCelerate"), an independent non-profit organization focused on accelerating the development of new medicines, today released a position paper outlining a methodology for risk-based site monitoring ("Risk-Based Monitoring" or "RBM") that could significantly modernize and streamline the way studies are conducted and monitored.  The RBM position paper reflects TransCelerate's collaborative approach to improve speed, efficiency and capabilities in bringing new therapeutics to patients.  With the release of the paper, the now sixteen-member organization delivers the first major milestone of its five clinical trials initiatives.

When it launched in September 2012 – founded by major healthcare, pharmaceutical and biopharmaceutical companies – TransCelerate chose to focus on five initiatives related to clinical trial efficiency.  Specific to the Risk-Based Monitoring initiative, the organization's goal was to establish a common approach to high-quality, risk-based site monitoring to enhance patient safety, ensure the quality of clinical data, and create efficiencies.

"Biopharmaceutical companies often spend an extraordinary amount of effort monitoring clinical trials – data from each patient, for every study, at every global site, is reviewed – yet, there isn't much evidence to indicate that this level of review is effective at identifying systemic errors or substantially improving the quality of data gathered," said Dalvir Gill , PhD, Chief Executive Officer of TransCelerate.  "Despite this, monitoring approaches have remained unchanged.  In this position paper, we have outlined a methodology – procedures, algorithms, a toolkit – for risk-based monitoring that we believe will be effective and efficient for our member companies and others."

The TransCelerate RBM methodology shifts monitoring processes from excessive concentration on source data verification to comprehensive risk-driven monitoring – moving away from the traditionally reactive industry approach.  Instead of relying heavily on on-site monitoring, which severely limits the ability to identify and prevent issues, TransCelerate's recommendations are driven by centralized and off-site monitoring techniques, as well as adaptive on-site monitoring.  This approach makes it possible to oversee study parameters holistically and maximize on-site monitoring findings, bringing into balance effort and value gained, while mitigating risks and detecting any issues early, or preventing them entirely.

The RBM paper outlines a standard approach for risk-based monitoring that can be adopted for any type, phase, and stage of clinical trial, resulting in enhanced patient safety, quality clinical data and new efficiencies.  The position paper was developed in response to draft guidance from the US Food and Drug Administration (FDA) and European Medicines Agency (EMA).  Both agencies have reviewed the RBM methodology paper and TransCelerate looks forward to the agencies' final guidance documents.

"TransCelerate's RBM methodology provides the framework and tools to manage clinical trial risks through identification, categorization and appropriate mitigation.  We are providing tools like the RACT (Risk Assessment and Categorization Tool) and the IQRMP (Integrated Quality and Risk Management Plan), which will help companies identify and plan their risk mitigation strategies.  We also are sharing an approach that enables a balance between off-site/centralized study monitoring and on-site activities at the investigative site.  This allows for a more targeted approach," said Rehbar Tayyabkhan, Executive Director at Bristol-Myers Squibb and RBM Project Lead for TransCelerate.

The RBM methodology position paper is available for public review and comment here.  TransCelerate invites feedback through a survey paired with the paper.  The organization's member companies will pilot its RBM methodology; multiple pilots already are in motion.  Lessons gleaned from these pilots, along with feedback from the Association for Clinical Research Organizations, Clinical Trials Transformation Initiative and the public, will help inform the methodology as needed. 

TransCelerate's RBM methodology also will be featured in a session at the Drug Information Association's (DIA) 49th Annual Meeting this month in Boston.  Following completion of pilot activities, TransCelerate plans to issue a future position paper clarifying the effectiveness of its approach.

About TransCelerate BioPharma Inc.

TransCelerate BioPharma Inc. was formed in 2012 and is a non-profit organization focused on advancing innovation in research and development (R&D), identifying and solving common R&D challenges and further improving patient safety, with the goal of delivering more high quality medicines to patients.  TransCelerate evolved from discussions at various forums for executive R&D leadership to discuss relevant issues facing the industry and solutions for addressing common challenges.  Founding members include AbbVie, AstraZeneca, Boehringer Ingelheim, Bristol-Myers Squibb, Eli Lilly and Company, GlaxoSmithKline, Johnson & Johnson, Pfizer, Roche, and Sanofi, and all have representation on the Board of Directors.  Additional members include Astellas Pharma Inc., Biogen Idec, Braeburn Pharmaceuticals, EMD Serono, Inc. (a subsidiary of Merck KGaA, Darmstadt, Germany), Forest Research Institute (a subsidiary of Forest Laboratories, Inc.) and Onyx Pharmaceuticals.

Membership in TransCelerate is open to all pharmaceutical and biotechnology companies who can contribute to and benefit from these shared solutions.  Executive offices are located in Philadelphia, PA. For more information, please visit

Media Contacts:

Chair – TransCelerate BioPharma Inc. Communications Committee 
Seema Kumar 
(908) 218-6460

Shannon Caudill 
(740) 281-3715 or (614) 378-9042

SOURCE TransCelerate BioPharma Inc.
Copyright©2012 PR Newswire.
All rights reserved

Related medicine technology :

1. TransCelerate BioPharma Inc. Grows, Strengthens Novel Effort to Accelerate Drug Development
2. New Prefillable Syringe System Offers Advanced Glass Technology for Biopharmaceutical Injectable Drug Delivery
3. Array BioPharma To Present At The Jefferies 2013 Global Healthcare Conference
4. RuiYi et Genor BioPharma collaborent au développement du RYI-008 en Chine, un nouveau traitement contre les maladies auto-immunes et le cancer
5. RuiYi and Genor BioPharma Collaborate on Development in China of RYI-008, a Novel Therapeutic for Autoimmune Diseases and Cancer
6. Array BioPharma Announces Clinical Data Presentations At The 2013 ASCO Annual Meeting
7. Callidus Biopharma Announces $4.6 million in Series A Financing to Pursue Orphan Disease Therapies
8. Keryx Biopharmaceuticals, Inc. Announces First Quarter 2013 Financial Results
9. Array BioPharma Reports Financial Results for the Third Quarter of Fiscal 2013
10. PDL BioPharma to Announce First Quarter 2013 Financial Results on May 9, 2013
11. Rutgers Business School and the Blanche and Irwin Lerner Center will explore trends and issues facing the biopharmaceutical industry at a healthcare symposium, Tuesday, April 30
Post Your Comments:
(Date:11/26/2015)... Nov. 26, 2015 Research and Markets ( ... Cardiac Pacemaker Market Outlook to 2019 - Rise in Cardiac ... " report to their offering. ... Boston scientific and others. --> ... Medtronic, Biotronik, Boston scientific and others. ...
(Date:11/26/2015)... ) has ... Future Horizons and Growth Strategies in the ... Shares, Country Segment Forecasts, Competitive Intelligence, Emerging ... --> ) has announced the ... and Growth Strategies in the French Drugs ...
(Date:11/26/2015)... STOCKHOLM , November 26, 2015 /PRNewswire/ ... --> Juntendo universitetssjukhus ser potential att ... av magnetresonansbilder (MR-bilder) för patienter med ... tecknat ett forskningsavtal med SyntheticMR AB för ... kliniska forskningsprojekt på sjukhuset. Med SyMRI kan ...
Breaking Medicine Technology:
(Date:11/27/2015)... ... November 27, 2015 , ... ... well-respected Microsoft Dynamics SL User Group (MSDSLUG). Recognized as Microsoft’s official group for ... of Microsoft Dynamics SL software users, partners, industry experts and representatives. Intellitec Solutions’ ...
(Date:11/27/2015)... ... , ... CBD College is proud to announce that on November ... to its Diagnostic Medical Sonography program. CBD College is honored to join this very ... and universities in the state of California make the cut. CBD College is officially ...
(Date:11/27/2015)... (PRWEB) , ... November 27, 2015 , ... ... contact center software Q-Suite, announces the incorporation of Asterisk 11 LTS (Long Term ... fully supported Asterisk 11 LTS brings Q-Suite 5.10 up-to-date with a version of ...
(Date:11/26/2015)... Ashburn, VA (PRWEB) , ... November 26, 2015 ... ... Planners, an American Express Travel Representative. As a franchise owner, Somu now offers ... range of cruise, destination wedding packages, private cruise sales, as well as, cabin ...
(Date:11/26/2015)... ... November 26, 2015 , ... WorldCare International, ... in the 61st annual Employee Benefits Conference. The Employee Benefits Conference was hosted ... 8th through Wednesday, November 11th, 2015. The conference was held at the Hawaii ...
Breaking Medicine News(10 mins):