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Medidata Solutions (NASDAQ: MDSO) will showcase new products and features that broaden its clinical cloud platform at the upcoming
Drug Information Association’s (DIA) Annual Meeting, June 24-28 in Philadelphia, Pa. Addressing new industry regulations, the need for broad safety reporting and improvements to site monitoring processes, these enhancements to Medidata’s comprehensive solutions will offer drug developers new capabilities for overcoming key research challenges.
“Sponsors are under more pressure than ever to cut costs, improve efficiency and adhere to increased regulations, requiring innovation and real-time operational analytics across the clinical research chain from concept to conclusion,” said Glen de Vries, president of Medidata Solutions. “We are continuously broadening our solution set to empower sponsors to improve their research clinical systems at every point in the clinical process, including trial planning, monitoring, site payments and safety.”
From booth #3101, Medidata will be providing demos of key products and new features to enable sponsors to achieve key goals, including:
Driving a New Monitoring ParadigmThe company’s first solution for managing site quality and the latest addition to the Medidata Insights™ family of clinical business analytics offerings, Medidata Insights SQM™ combines advanced data visualization with seamless real-time data availability with the rest of Medidata's platform to deliver turnkey site quality management – further enabling the industry’s shift to simplified remote monitoring of site and data quality resulting from the 2011 FDA clarification on source document verification (SDV).
Automating Safety Processes with Electronic Adverse Event TransferTo help drug developers meet post-marketing expedited reporting obligations within the new European pharmacovigilance legislation, Medidata Rave Safety Gateway™ expanded its capabilities for sites to electronically transfer non-serious safety case data – in addition to serious safety case data – to sponsors' safety systems, eliminating paper-based manual processes, reducing query cycles between sites and sponsors’ safety groups and minimizing reconciliation between safety and clinical databases.
Ensuring Timely Investigator PaymentsDue to the complexity of triggering investigator payments from sponsor-set milestones, site payments are often delayed. The out-of-the box integration of Medidata CTMS™ and Medidata Rave® electronic data capture (EDC) improves the efficiency of clinical operations, streamlining workflows in areas such as site monitoring and site payments. Now, Medidata Rave EDC data is pulled into Medidata CTMS™ monitor reports, increasing the accuracy of reporting and timeliness of payment triggers.
Assuring Market Value Compliance and Faster Budget AgreementsDesigned for sponsors receiving investigator-sponsored proposals from sites, Medidata Grants Manager Investigator Initiated™ offers drug developers clarity and uniformity in judging pricing and conduct of their submitted funding requests.
Ensuring the Right Randomization Approach to Meet Study GoalsMedidata Balance™ now provides the block randomization methodology in addition to dynamic allocation randomization, extending its use to new segments of the life science industry by permitting researchers to use the approach that best suits their study goals.
About Medidata Solutions WorldwideMedidata Solutions is a leading global provider of cloud-based clinical development solutions that enhance the efficiency of customers’ clinical trials. Medidata’s advanced platform lowers the total cost of clinical development by optimizing clinical trials from concept to conclusion: from study and protocol design, trial planning and budgeting, site negotiation, clinical portal, trial management, randomization and trial supply management, clinical data capture and management, safety events capture, medical coding to business analytics. Our diverse life science customer base spans biopharmaceutical companies, medical device and diagnostic companies, academic and government institutions, CROs and other research organizations, and includes more than 20 of the top 25 global pharmaceutical companies as well as organizations of all sizes developing life-enhancing medical treatments and diagnostics.