eSource Publication in Applied Clinical Trials
Applied Clinical Trials has published our article in the June/July print edition as part of 4 articles on Clinical Trial Optimization. The article, entitled Three-Pronged Approach to Optimizing Trial Monitoring Study – Results Using a Quality-by-Design [QbD] Method, Risk-Based Monitoring [RBM], and Real-Time Direct Data Entry [DDE], reports the results of the clinical trial initiated in the U.S. and Canada, which included 18 sites and 180 treated subjects where all the sites performed DDE and all the clinical research associates (CRAs) performed RBM, with the bulk of monitoring activities occurring centrally from the home office (central monitoring). For this publication, Target e*CRF® was used for EDC, Target e*CTR® Viewer was used to access the eSource records, and Target Document was used as the eTMF.
We are currently planning a PMA submission this year and an NDA next year, where the sites will have performed DDE at the time of the office visit and the CRAs, as part of the QbD methodology, will have performed RBM and central monitoring. We are also starting our 17th and 18th studies using DDE. There are 10 IND and 1 IDE programs, with the largest study being up to 45 centers and up to 400 subjects.
We are fully web-based so our system can be run using any Internet browser and at any time. We also create a certified Independent contemporaneous copy (CICC) of the eSource record before the data hit our EDC database, which is consistent with both the FDA Guidance and EMA Reflection Paper on eSource Records. We are also planning full integration with the electronic medical record (EMR) within the year with a clinical trial planned for Q3 2014. This program is being funded by the Bird Foundation.
We welcome collaboration with other EDC systems as we believe our solutions to DDE and EMR integration will be the industry standard.
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