MALVERN, Pa.,--(BUSINESS WIRE)--OPKO Health, Inc., a multinational pharmaceutical & diagnostics company, has selected DSG’s eCaseLink integrated suite for self-building of harmonized electronic data capture (EDC), IWRS, drug safety event capture and case reporting, and CTMS systems. DSG’s team will support the OPKO team and their Site users 24 x 365.
DSG’s Drug Safety, a comprehensive adverse event management system developed by DSG as part of an integrated suite including EDC, IWRS, and CTMS, streamlines the safety recording, reporting process, data entry on Serious Adverse Events (SAEs), storing associated documents facilitating the generation and tracking of queries. Features include integration with other regulatory and management systems, ICH E2B compliance, and generating FDA 3500A MedWatch and CIOMS forms, exporting data as required. Sponsors configure the system to accommodate unique workflows and procedures more efficiently.
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