DENVER, Oct. 3, 2018 /PRNewswire-PRWeb/ -- Pharma, Biotech, Device, and Vaccine manufacturers use the latest scientific
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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