Full-service CRO Offers New Capabilities in Adverse Event Reporting with Leading Safety Integration Tool
NEW YORK--(BUSINESS WIRE)-- Medidata Solutions (NASDAQ: MDSO), a leading global provider of SaaS-based clinical development solutions, today announced that Synteract, Inc. has become accredited in Rave Safety Gateway, a secure, configurable electronic data capture (EDC)-to-safety-system interface. A Medidata channel partner since May 2010, Synteract is a full-service contract research organization (CRO) and the first to attain one of Medidata’s new Partner Program accreditations.
Since 2008, Medidata has offered a partner accreditation for Medidata Rave®, a leading system for clinical data capture, management and reporting. In support of customer demand for its growing product portfolio, Medidata recently expanded its program to offer eight product accreditations to Medidata Services Partners. In June 2011, Synteract attained the Rave accreditation to provide the full suite of Medidata Rave services to sponsors.
With its strong focus on customer service, Synteract pursued the Rave Safety Gateway accreditation to offer sponsors a more efficient and accurate tool to perform the time-critical task of collecting and transmitting serious adverse events (SAEs) and related data from sites to safety reporting systems. Synteract learned and reviewed two versions of Safety Gateway and also provided feedback to enhance it as part of Medidata’s customer-centric product development process.
“With this Safety Gateway accreditation, we now can provide sponsors with a much more effective way to process real-time safety data by reducing the time and resources previously required to manage multiple systems,” said Stewart Bieler, COO of Synteract. “We thrive on our ability to flexibly add new services and technologies, and this accreditation allows us to improve the process of safety data collection and management – a critical area for all sponsors.”
After completing in depth face-to-face interactive training workshops on Safety Gateway applications to learn best practices to map Rave with sponsor safety systems, Synteract was recognized with the Safety Gateway accreditation. Synteract is already leveraging Safety Gateway for a pharmaceutical company conducting two Phase III trials.
“More and more sponsors are looking for ways to efficiently transfer safety data from the Rave EDC system into E2B-compliant pharmacovigilance systems – saving both time and money while maintaining the quality of their data,” said Graham Bunn, vice president of partnerships, Medidata Solutions. “Synteract’s accreditation further validates the demand for Medidata’s growing portfolio of products and our continued commitment to helping partners and sponsors maximize the value of all our solutions across the clinical development chain.”
Medidata first announced its channel partner program in April 2005 to enable select CROs and other service providers to offer services in support of Medidata products. Since then, the program has grown to include about 30 partners, ranging from smaller clinical consultancies to large, global CROs.
Synteract is a privately-held, full-service contract research organization, serving clinical trial needs of biotechnology, medical device and pharmaceutical companies. Synteract provides high-quality, customized service, working closely with drug and device sponsors. Headquartered in California, with offices in North Carolina and Czech Republic, Synteract offers clinical expertise in multiple therapeutic areas, including a strong emphasis in oncology, central nervous system (CNS), cardiovascular, respiratory and ophthalmology.
About Medidata Solutions Worldwide
Medidata Solutions is a leading global provider of SaaS clinical development solutions that enhance the efficiency of customers’ clinical trials. Medidata’s advanced solutions lower 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.
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