SGS Life Science Services Uses Electronic Data Capture to Accelerate Pharmaceutical Test Designs and Automate Testing Processes
 
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SGS Life Science Services Uses Electronic Data Capture to Accelerate Pharmaceutical Test Designs and Automate Testing Processes

  • Oracle Customer:  SGS Group
    Location:  Antwerp, Belgium
    Industry:  Life Sciences
    Annual Revenue:  Over $5 Billion

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. 

 
 

 
 

Challenges

A word from SGS Group

  • “Oracle Health Sciences InForm Global Trial Manager helped us to accelerate the entire trial process, from design and data input, to management and analysis―and it has improved transparency. The solution is the key to our ability to deliver comprehensive and efficient clinical trial services.” – Joris de Bondt, Head of EDC, SGS Group

  • Implement a powerful and reliable EDC platform that improves clinical trial efficiency, expands transparency in managing trials, and ensures data quality
  • Gain a competitive edge by offering clients comprehensive and proven clinical trial management services from a single vendor
  • Enable sponsors and those who manage testing sites to accelerate study design and execution without sacrificing quality, helping to speed time to market
  • Automate data input to reduce manual processes, improve data quality, and mitigate risk of errors
  • Integrate with a variety of IVRS/IWRS systems
  • Establish pharmaceutical testing process transparency and improve ability to make real-time adjustments to ensure trial integrity and efficiency

Solutions

  • Implemented Oracle Health Sciences InForm Global Trial Manager for a reliable and flexible platform that manages all aspects of clinical studies, from planning and design, to data management, reporting, and analysis
  • Established a one-stop-shop for end-to-end clinical trial management services, which saves customers time, as they no longer have to work with and manage multiple suppliers
  • Reduced study-build time, which, depending on study complexity and re-usability of library eCRF forms, takes an average of five weeks, relying less on third parties through use of extensive eCRF libraries, including CDISC CDASH forms in Oracle Health Sciences Central Designer
  • Accelerated launch of studies spanning an average user acceptance testing (UAT) cycle of two-weeks through an efficient UAT process that is based on rapid execution by the large group of experienced SGS testers executing test scripts in parallel, and that, with efficient use of library eCRF forms, can shorten UAT to one week
  • Automated data input and query generation via an EDC platform―eliminating the need to rekey data, which improves quality, prevents errors, and saves time and costs
  • Simplified data verification and enhanced consistency using data viewer, which automatically signals deviating values and enables multiple pages to be locked at once
  • Reduced database lock times from an average of 30 days to 17 days by optimizing workflows, which means that trial managers can start statistical analysis sooner—saving time and reducing costs