Announces Oracle AERS Platform Implemented for Collection of Safety Data

Chicago, Il. – Radiant Development, the CRO division of Radiant Research, Inc., today announced that it has completed full implementation of the AERS platform for the collection of safety data for both pre-approval and post-marketed products.

“This powerful database will allow full monitoring of safety data from a single event to an analysis of trends for a medication,” said Vita Lanoce, Vice President of Radiant Development. “We will be able to provide this analysis for sponsors of drugs, devices, vaccines and nutritional products and also assist them in the submission of data to the regulatory authorities.”

The Oracle AERS platform is a fully validated safety database that allows for data entry and reconciliation of adverse events, medical review and narrative completion and expedited reporting for submission to regulatory authorities. In conjunction with the implementation of the system, Radiant has also added IT staffing and around the clock medical support to facilitate reporting and compliance with strict regulatory guidelines.

“Patient safety is paramount,” said Dr. Joan Drucker, Chief Medical Officer for Radiant Development. “A good safety plan should start with the first clinical trial and expand throughout the product lifecycle. We are thrilled to extend our service offering to provide our clients with the premier system for safety monitoring.”

With the earlier announcement of Radiant’s expansion into India through its partnership with Spectrum Clinical Research, Radiant can now offer pharmacovigilance services for global clinical trials as part of its comprehensive pre- and post marketing safety services.

About Radiant Development:

Based in Chicago, IL, Radiant Development (www.radiantdevelopment.com) is a full-service CRO founded in 1995.  The range of services includes medical affairs, site selection, project management, clinical monitoring and site management, data management, biostatistics, medical writing, and quality assurance.  In addition, specialized services such as protocol design, expert patient recruitment planning and execution, as well as scientific and regulatory consulting are available.  Historically, Radiant Development's past clinical trials supported NDAs, supplemental indications, advertising statements, and health claim petitions.

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