OPKO Health, a multinational pharmaceutical and diagnostics company, has selected Malvern, Pa.-based 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.
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.
DSG’s flagship EDC software, eCaseLink, in continuous use since 1999, provides system builders with an intuitive tool, DSG Designer, enabling unlimited quantities of cross-visit edits on eCRFs without compromising system performance, a proprietary technology unique to DSG. Other helpful features include risk-based monitoring, 3rd-party system data integration, module for managing local lab Normals, integrated MedDRA/WHO drug auto-interactive encoder, ad-hoc reporting, SAS datasets on demand, patient profiles, protocol deviations, image upload and management, unlimited auto-emails, auto-population between eCRFs, Innovation Award-winning IWRS and also data management dashboard, integrated training modules and DSG.