PROMETRIKA, LLC, is proud to announce it has recently achieved accreditation on Medidata Rave Targeted SDV. Rave TSDV increases the efficiency of on-site monitoring by identifying specific data points that require assessment by monitors. Ultimately, both data quality and regulatory compliance are enhanced. Adding this tool to PROMETRIKA’s suite of Medidata products strengthens the ability to design, configure, and execute a risk-based monitoring strategy.
PROMETRIKA’s Head of Clinical Operations, Ms. Heather Paden, said “Tools such as Medidata Rave TSDV allow us to focus our monitor’s time reviewing the data endpoints that are truly critical to a trial’s success. It frees them up to do things we cannot do centrally, like drug accountability, to ensure PI oversight.” Last year Ms. Paden was invited to Medidata’s 2018 NEXT conference in NYC to present The Era of Flexible Monitoring: Centralized Data Review and TSDV. You can view her presentation here.
“PROMETRIKA has been strong Medidata partner for several years,” said Janet Butler, SVP Global Partnerships and Enterprise Accounts, Medidata. “This is the fourth accredited module for the Cambridge-based CRO, and we are delighted to strengthen our successful relationship with them. We look forward to our continuing and growing collaboration that leverages the power of the Medidata Rave Clinical Cloud™.”
ABOUT PROMETRIKA, LLC
Founded in 2003 and based in Cambridge, Massachusetts, PROMETRIKA is a unique Clinical Research Organization, utilizing a collaborative approach to clinical development and execution with a close-knit, highly-experienced senior leadership team that remains involved throughout the duration of each trial. PROMETRIKA’s services include complete clinical operations and clinical trial management, data management, pharmacovigilance, biostatistics and programming, medical writing, and regulatory submissions.
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