Global Not For Profit Empowered by Standardization of Technology and Clinical Data
A global not-for-profit research organization with operations in both the US and Africa was planning numerous, multi-phase studies to support their development of treatments to battle infectious disease. Their development program consisted of global trials in remote regions, including Africa, as they strived to eradicate inflictions that affect millions of people globally. With the need to partner with geographically aligned service partners for site, patient, and regulatory considerations, the organization lacked consistency in data acquisition technologies and identified significant gaps in needed functionality from the various platforms they previously utilized. The organization strived to:
- utilize various geographically established service partners that understood the clinical development landscape for the specific region, but maintain consistency in technologies implemented and leverage previous technical and training efforts
- identify appropriate technologies that have robust functionality, such as the ability to integrate local lab data, and can support global trials with sites and patients in remote parts of the world
- implement clinical data standards to better utilize all data collected regardless of clinical system or trial that data was collected during
- implement robust visualizations and easily to use reporting structures for data analysis from a cross-trial perspective, down to patient level
eClinical Solutions consulted with the organization and introduced their team to the Medidata clinical cloud and its suite of products to address their electronic data capture needs. eClinical data conversion experts discussed a data standardization strategy that would provide submission ready clinical data, as well as enabling their team greater utilization of what was being collected for review and analysis. The eClinical Solutions team interviewed key stakeholders, including the organization’s other contracted service partners, to understand their data utilization needs to include clinical site monitoring, data management process, and safety monitoring.
- eClinical Solutions teamed with Medidata and implemented Medidata’s Rave EDC platform on a program level, utilizing CDASH standards to allow reusability during the configuration process from study to study. The eClinical team also implemented Medidata’s Safety Gateway for efficient transformation of reported safety events from Rave to the utilized safety database.
- The eClinical Solutions team converted all collected clinical data to SDTM standards, enabling efficient utilization of the now submission ready data for cross-trial analysis and multi-source views.
- eClinical Solutions implemented their innovative elluminate® clinical data repository to aggregate the client’s complete dossier of clinical and operational data, all standardized, for powerful on-demand visualization and analytics.
- eClinical Solutions collected user requirements and data utilization specifications from stakeholders both at the client, as well as the various regional CROs used to customize views and reporting structures for operational efficiencies.
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