The Irish firm says its new system – a central, global, web-based source – will become part of its technology solution Iconik, enabling it to standardise trial processes as well as improving analysis capabilities.
The program has a full role based security model integrated within it, and complies with the USA FDA’s 21 CFR Part 11 regulation, which means that Oracle will provide full and regular maintenance of the software.
Mike McGrath, Icon’s senior VP information technology, told Outsourcing-Pharma that the new capabilities will allow for a quicker, cleaner trail.
He said: "This functionality enables data to be sorted, related and searched, providing operational and clinical benefits.
“Trials can be set up and closed more quickly without a need for sponsor side re-aggregation of data into a separate master clinical database.”
McGrath also said that the new program would be integrated with other tools within the Iconik program to allow online presentation and analysis of safety signals in both clinical and laboratory markers.
He added: “This allows for more optimal safety assessments and oversight.”
Overcoming challenges
However implementing the new database has not been without its hurdles, not least aligning data from multiple sources.
McGrath said: “There are obviously challenges in integrating various data sources especially when many of the leading EDC systems are SaaS applications hosted in the cloud.
“However by far the biggest challenges are in data transformation i.e. aligning common data for multiple sources in order to standardise and report across it.”
But the company persevered after it recognized the need for an improved system based on general demand.
“It was a strategic decision based on an overall demand for improved clinical data reporting & analytics and improved management and auditing of customer data,” McGrath added.