SGS Group is a leading inspection, verification, testing, and certification company with over 70,000 employees in more than 1,350 offices globally. The Life Science Services business unit is a contract research organization (CRO) that offers pharmaceutical and biopharmaceutical customers a complete range of services to manage and test the quality and safety of components and development processes. SGS services range from preclinical activities to phase I-IV trials, including analytical laboratory testing with a network of 19 labs across the European Union, United States, and Asia. In addition, SGS offers its international customers full analysis services, helping them to optimize development processes and improve decision-making to enhance efficiency, reduce costs and ensure pharmaceutical product safety and quality.
SGS Life Science Services wanted to migrate from a paper-based clinical data capture process to an electronic data capture (EDC) platform to efficiently support more customers. In addition, it wanted to automate core processes, enabling more efficient planning and conducting studies for its clients. To accomplish these goals, SGS implemented Oracle Health Sciences InForm Global Trial Manager in 2008. The SGS team meanwhile processed data from more than 40 large, InForm trials that included over 15,000 patients, with thorough, standard operating procedures in place to streamline and harmonize all aspects of the EDC trials.
With the implementation, the SGS Clinical Trial Services business unit acquired an electronic data capture (EDC) solution that accelerates study design, provides robust data management, and increases data transparency. It gained user-friendly reports and advanced analytical options that enable staff and customers to easily control the entire clinical trial management process. By also implementing Oracle Health Sciences Central Designer, SGS Life Science Services can now set up and run the entire trial process for its clients, strengthening its position as a market leader.
SGS has streamlined the EDC set-up process by centralizing all required skills on a single, EDC team that translates protocol requirements into electronic case report forms (eCRF) that may be copied from the extensive eCRF library, including clinical data interchange standards consortium clinical data acquisition standards harmonization (CDISC CDASH) forms managed by this team. The use and reuse of library forms when building EDC trials can significantly reduce the eCRF design time and user acceptance testing efforts. In addition, technical EDC experts take care of IT-related EDC challenges, from complex programming edits, to follow-ups on interactive voice response system/interactive Web response systems (IVRS/IWRS) integrations.