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03-Oct-2018

Applied Clinical Trials Publishes First Head to Head Comparison of Clinical Trial Oversight Methods

Applied Clinical Trials Publishes First Head to Head Comparison of Clinical Trial Oversight Methods Applied Clinical Trials publishes first head to head comparison of clinical trial oversight methods. The MANA Method proved to be superior to the traditional source document verification (SDV) approach.

PR Newswire

DENVER, Oct. 3, 2018

DENVER, Oct. 3, 2018 /PRNewswire-PRWeb/ -- Pharma, Biotech, Device, and Vaccine manufacturers use the latest scientific discoveries and technology to develop their products. In contrast, the traditional tool used to confirm whether the studies involving patients were conducted appropriately has not changed in over 30 years. The FDA and foreign regulators have tried to change clinical trial oversight methods since 2011 when they released the first of several Guidance Documents recommending a Risk-Based Monitoring (RBM) approach to monitoring clinical trials.

Applied Clinical Trials published the first head to head comparison of two different clinical trial oversight methods (http://www.appliedclinicaltrialsonline.com/comparing-risk-based-monitoring-and-remote-trial-management-vs-sdv?pageID=1). This pilot study compared traditional monitoring visits to each research site for source document verification (SDV) versus one RBM Method, the MANA Method. The MANA Method is a new, remote trial oversight approach focused on identifying and correcting the "errors that matter" remotely. The MANA Method proved to be superior to the traditional SDV approach.

"This is important research for those of us who conduct clinical trials. I'm pleased that our PaxVax Team, MANA RBM, and Integrated Clinical Systems collaborated to evaluate these two different oversight approaches and contribute our findings to the scientific literature," said Lisa Danzig, M.D., Chief Medical Officer at PaxVax.

"MANA RBM is committed to creating, developing, and using the most scientific, rigorous methods to conduct and oversee clinical trials. This commitment includes proving our methods are superior to traditional approaches. We provide evidence-based data to pharma/biotech and vaccine companies to allow them the opportunity to adopt proven methods that meet the same scientific rigor they use to discover new compounds and treatments," said Penelope Manasco, M.D., CEO of MANA RBM, "The MANA Method identifies and corrects the 'errors that matter' faster; errors that can negatively affect the ultimate analysis of efficacy, decrease the safety of all study participants, and dramatically affect the viability of the compound and its Sponsor."

For more information, contact Penelope Manasco, M.D., CEO, MANA RBM at pmanasco(at)manarbm.com or 919-556-9456.

 

SOURCE MANA RBM

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Last Updated: 03-Oct-2018