FOR IMMEDIATE RELEASE
Pharmacovigilance Services and Solutions Organization Leverages Rave Safety Gateway for
Simple and Fast Integration of Medidata Rave EDC/CDM with Drug Safety Systems
NEW YORK, N.Y. – November 17, 2010 – Medidata Solutions (NASDAQ: MDSO), a leading global provider of SaaS-based clinical technology solutions, today announced the addition of Sentrx, a specialty provider of pharmacovigilance services and solutions, as a member of its Technology Partner Program. The partnership recognizes Sentrx for its support of Medidata Rave® Safety Gateway, a configurable electronic data capture (EDC)-to-safety system interface, to help sponsors benefit from the ability to efficiently collect, transmit and manage critical safety data.
Sentrx works with a range of biopharmaceutical organizations to improve safety management using best-of-breed clinical technologies. As a result, Sentrx’s clients are often faced with the challenge of integrating EDC systems with drug safety systems. By leveraging Rave Safety Gateway, Sentrx is able to overcome this complex challenge by using a more efficient and accurate solution that instantly transfers safety-related data from Medidata Rave, a leading system for electronic data capture, management and reporting, to any safety system using the International Conference on Harmonization industry standard E2B file format.
As a leading hosting provider of the Oracle Argus Safety application in North America, Sentrx is now able to serve its broad customer base with rapid EDC-to-safety system data transfers. Rave Safety Gateway enables Sentrx to help sponsors improve the experience of their clinical site investigators through elimination of duplicative data entry, while also reducing serious adverse event (SAE) reconciliation efforts. This minimizes chances for error, expedites reporting time and facilitates more rapid data analysis.
“We are focused on improving safety management in all phases of clinical trial development through the application of innovative technologies which help surface the value of safety data and contribute to the successful commercialization of new compounds. We are excited to partner with Medidata Solutions, which shares our commitment to streamline safety data collection, reporting and analysis,” said Charles Saldarini, CEO, Sentrx. “Rave Safety Gateway is a breakthrough solution that will be a major force in the next generation of trial execution precisely because it helps drive toward this outcome.”
The Medidata Technology Partner Program has recognized Sentrx for its demonstrated ability to help streamline safety data processes, including safety data management for continuing, real-time assessment during a trial as well as for reconciliation upon completion. By leveraging Rave Safety Gateway, Sentrx expects higher levels of clinical site investigator satisfaction, particularly in the ongoing, dynamic process of adverse event management.
“With increasing regulatory emphasis on safety throughout all phases of clinical development, sponsors that leverage approaches to expedite data sharing between EDC/CDM and safety solutions gain significant operational advantages, reducing the time and resources required to quickly and responsibly manage data that is critical for patients and the ultimate outcome of the sponsor's clinical studies,” said Glen de Vries, president, Medidata Solutions. “We are delighted to recognize Sentrx as a Medidata partner that understands this challenge and is responsive to customers who are looking to efficiently use safety solutions alongside Medidata Rave. Through the use of Rave Safety Gateway, Sentrx is now able to deliver enhanced safety technology solutions for sponsors’ Rave-based EDC trials around the globe.”
Since its introduction in June of 2009, Medidata’s Technology Partner Program has grown to include ten independent technology vendors that offer specialized solutions supporting data sharing with Medidata products in order to streamline and enhance the end-to-end e-Clinical process.
About Sentrx
We are drug safety experts. Our highly experienced teams focus in safety technology systems, adverse event management and medical affairs. Sentrx solutions include SaPh™, CROPlus™ and UniPhi™ and are customized, integrated and scalable to enhance efficiency, reduce cost, and improve flexibility. Our experience is unmatched, built over 15 years serving a broad range of bio-pharmaceutical clients, including CROs. To learn more about Sentrx, please visit www.sentrx.com.
About Medidata Solutions Worldwide
Medidata Solutions (www.mdsol.com) is a leading global provider of SaaS-based clinical development solutions that enhance the efficiency of customers’ clinical trials. For over 10 years, Medidata has consistently brought next-generation innovation to the life science industry to lower the total cost of clinical development through informed trial planning and management, optimized clinical processes and platform interoperability. Medidata’s advanced solutions address key functions throughout the clinical development process including protocol development (Medidata Designer®), trial planning and management (Medidata Grants Manager®, Medidata CRO Contractor®), user and learning management (iMedidata™), randomization and trial supply management (Medidata Balance™), monitoring (Medidata Rave Monitor, Medidata Rave Targeted SDV), Serious Adverse Events capture (Medidata Rave Safety Gateway) and clinical data capture, management and reporting (Medidata Rave®). Our diverse 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.
Contact:
Susan McCarron
Lois Paul & Partners
781.782.5767
Susan_McCarron@lpp.com