MakroCare’s Centralized Monitoring (CenMon™) solution offers a smarter, reliable, quality driven, and cost-efficient way to monitor and proactively manage various aspects of clinical trials. By aligning right customized processes, trained resources, robust technology and using ongoing statistical analyses of accumulated data, CenMon™ helps sponsor/CRO to achieve high data quality cost efficiently to meet their objectives.
With the release of the guidance document by FDA and the reflection paper by EMA, the biopharmaceuticals, medical device companies and CRO are actively embarking on this paradigm shift in clinical research to reap the benefits of Risk-Based Monitoring (RBM). MakroCare, a thought leader in RBM, offers a complete RBM solution by combing its process expertise and proprietary cutting edge technology. MakroCare offers consulting/advisory support for the implementation of RBM process, trained resources like risk manager, central monitor and also technology TULA, as a complete risk management platform through DDi which specializes in innovative technologies in clinical and regulatory space.
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