SAN JOSE, Calif., Feb. 27 /PRNewswire/ -- Clinimetrics Research Associates announced today that it has successfully completed the full integration of the Oracle(TM) Pharmaceutical Application Suite. The system is fully validated and includes Oracle(TM) Clinical, Oracle(TM) Clinical Remote Data Capture (RDC), Oracle(TM) Thesaurus Management System (TMS) and the most recent addition, Oracle(TM) Adverse Event Reporting System (AERS). With the addition of our expanded safety capabilities support all our clients' safety surveillance needs, including safety data collection, tracking, analysis and global regulatory reporting, maintaining strict compliance with all current and emerging safety regulations and guidance worldwide.
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Together with Oracle(TM) AERS, our Medical Safety Group supports all product types, including drugs, devices, vaccines, and gene therapies and additional services include product complaints and post marketing surveillance. With integrated multiple language capabilities and global reporting tools, we support all of our clients' product global safety requirements, including all submissions, such as expedited and periodic reporting, MedWatch, E2B and CIOMS.
"We are pleased to offer our clients an advanced suite of data management tools that seamlessly integrate data collection, review, query resolution, and provide analytical capability for adverse events. These technological enhancements will assist our clients in more rapid completion of final clinical reports and develop integrated safety databases that may be used for electronic submissions to any regulatory agency in the world," stated Brad Zaro, CEO of Clinimetrics.
Founded in 1988, Clinimetrics, Inc. is a global, full service contract research organization (CRO) that offers a complete array of integrated research services including clinical and data management, project management and biostatistics as well as quality assurance, regulatory and medical affairs. In addition, Clinimetrics also provides in-house staff, customized training programs, and integrated travel and event planning services for meetings and corporate functions. With Corporate Headquarters in San Jose, California and Operation Centers located regionally in San Diego, California, Atlanta, Georgia, Mississauga, Toronto (Canada), Maidenhead, United Kingdom and Sydney, Australia, Clinimetrics serves an international clientele of pharmaceutical, biotechnology and device companies. For more information, please visit our website: http://www.clinimetrics.com/.
Contact: Michelle Manrubia of Clinimetrics, 408-452-8215.
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