CDISC – What is it? Understanding SDTM, ADaM, define.xml

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Funded by over 430 member organizations, CDISC (Clinical Data Interchange Standards Consortium), is a global, non-profit data standards organization providing standards for data collection, sharing and analyses for clinical and non-clinical use. The standards are mandated for regulatory submissions to the U.S. FDA and Japan PMDA as of December 17, 2016, have been endorsed by the […]

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The Emergence of a “Risk Monitor”: Preparing for the future.

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Dr. Nimita Limaye, PhD CEO & Principal Consultant, Nymro Clinical Consulting Services Interviwed by By Artem Andrianov, Ph.D., MBA, CEO, Cyntegrity   Pharmaceutical companies and contract research organizations (CROs) are increasingly trying to leverage technology to optimize risk-based monitoring. While technology is a critical component, roles also need to be looked at again. Recently we […]

Twenty Five Key Questions associated with Vendor Selection for Risk Based Monitoring

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Dr. Nimita Limaye, CEO, Nymro Clinical Consulting Services  While Risk Based Monitoring (RBM) is as yet relatively nascent in the industry, it is gradually moving towards becoming the norm as a result of industry initiatives such as TransCelerate BioPharma and key guidances coming through from the FDA, EMA and the latest ICHE6 R2 guidance. While […]

Evolving data strategies and cost implications for clinical trials

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Dr. Nimita Limaye, PhD CEO & Principal Consultant, Nymro Clinical Consulting Services Interviwed by Dr. Manoj Jadhav PhD, FCP Translational Clinical Pharmacologist, CRC Pharma, LLC., New Jersey, USA About Dr. Nimita Limaye, CEO & Principal Consultant, Nymro Clinical Consulting Services, has over twenty years of experience working across the global and local Pharma and CRO […]