Dublin-based clinical research player ICON plc has teamed up with the web-based Oracle Life Sciences Data Hub, which will enable it to standardise and more efficiently manage hundreds of ongoing clinical studies online.
ICON has created a central, global, web-based repository that will enable it to standardise processes and facilitate analysis of clinical trial data, driving increased efficiency across the business. By building a single, global integration and reporting platform, ICON will have the foundation in place to store and analyse all clinical data more efficiently and effectively.
The solution, which enables ICON to monitor and control the chain and custody of data, will support regulatory compliance. Oracle Life Sciences Data Hub provides enhanced audit trails to ensure compliance with 21CFR Part 11 regulations.
Using Oracle Life Sciences Data Hub, ICON can integrate multiple data sources and systems to provide discipline, structure and a more efficient process for collecting, cleaning and analysing clinical data across ICON’s global operations.
Expanded data analysis and reporting capabilities
“Every clinical trial is different, from its data sources to its reporting requirements. Managing hundreds of trials at any time, ICON needed a data repository that would allow us to standardise processes to drive new efficiency, while also meeting complex compliance requirements,” said Mike McGrath, senior vice-president, Information Technology, ICON plc.
“Oracle Life Sciences Data Hub meets these needs and supports expanded data analysis and reporting capabilities. It is fundamental to realising our vision of creating a single hub for all clinical data that can help to deliver new insight while ensuring the integrity of trial data.”
ICON is the first CRO to implement Oracle Life Sciences Data Hub as part of its new ICONIK platform which provides integrated patient and study reporting to study teams and clients.
ICON plans to expand its use of reporting technologies to increase the visibility and availability of clinical trial data and associated metrics.
“To optimise the value they bring to their health sciences clients, CROs must increasingly focus on improving the efficiency and productivity of the clinical trials they manage,” said Neil de Crescenzo, senior vice-president and general manager, Oracle Health Sciences.
“Oracle Life Sciences Data Hub helps CROs advance this objective by creating a single, validated and secure repository for clinical, non-clinical and safety data from multiple sources. This unified data approach enables streamlined business processes around trial data acquisition, analysis and reporting,” de Crescenzo said.