Support sites with integrated solutions that ensure robust risk management, reduced source document verification (SDV), and real-time monitoring. Even the most experienced clinical trial sites can encounter difficulty and delays recruiting patients, ensuring quality, and getting paid. A small sub-set of sites that experience difficulty can adversely affect an entire study’s quality, cost, and speed. Medidata supports sites with advanced capabilities spanning trial assurance, site-quality management, and risk-based monitoring.
Medidata is really knowledgeable about RBM. They knew exactly what we needed and exactly where to lead us. They helped us build our risk management plan and develop our KRI’s.
– Julia Auer, Clinical Trial Manager, Tesaro Bio
We chose to partner with Medidata because of its innovative technology and ability to integrate and automate site payments with EDC
– Max Barker, general counsel and VP, finance at Polaris Pharmaceuticals.
Are you launching a risk-based monitoring (RBM) study? You don’t need to blaze the trail. With Medidata RBM, design and conduct any RBM program in real time. Medidata RBM combines cloud technology and strategic consulting services so you can quickly realize the quality, cost and timeline benefits of RBM.Learn more
A monitoring solution wouldn’t be complete without the tools that clinical research associates (CRAs) need to efficiently manage site monitoring activities and create visit reports.
Medidata’s cloud-based on-site monitoring module is integrated with EDC—providing smart workflows and structured visit reports that pull data directly from EDC to save CRAs time and improve the quality of data and documents.Learn more
Can you quickly identify which investigator sites are capturing accurate clinical data from patients, and those that aren’t? If you're relying on anecdotal information or past performance records, probably not.
Medidata SQM alerts your study team to quality changes at sites while your study is still in progress.Learn more
Targeted Source Document Verification (TSDV) devours more than 15 percent of trial budgets. Yet research shows that verifying every data point does not significantly improve data quality. Instead, what if you could automatically target SDV where you need it most?
Medidata TSDV lets you reduce SDV coverage without sacrificing data quality or regulatory compliance.Learn more