Oracle launches new clinical data integration software
companies integrate clinical data from multiple sources and
streamline regulatory compliance in the clinical development
process. Pharma giant Boehringer Ingelheim is the first company to
jump on board.
The software brings new life to the process of collecting and analysing the data in clinical trials, which has essentially remained static over the last 20 years.
In order to effectively manage clinical development, companies must constantly monitor regulatory compliance and have access to information from a variety of systems, including trial management, pharmacokinetic/pharmacodynamic (PK/PD), electronic data capture (EDC), clinical patient data, central lab and pharmacovigilance systems.
Many companies have implemented complex and costly integration projects that attempt to pull data from these multiple systems into a single warehouse.
However, because of the complexity of maintaining the transformations and interdependencies of the underlying data, these efforts often result in an unmanageable set of point-to-point solutions with very little infrastructure or documentation supporting the critical central repository.
"The Oracle Clinical Data Repository helps to overcome such integration problems by managing all aspects of the integration process - data access, transformation, persistence and distribution - in a compliant framework," said Mychelle Mowry, vice president for Global Health Industries at Oracle.
Tougher regulatory measures are also pushing pharma companies to standardise the way they manage their clinical data, as well as how they format and structure the data for submission to regulators around the world.
"Oracle Clinical Data Repository will enable organizations to address these regulatory requirements by providing a controlled, structured environment in which to build and store clinical information in a ready-to-submit format," said Mowry.
The software package provides the user with the ability to manage the complete workflow process, defining the data repository structure; developing and validating the programs that analyse and report the data; and controlling access to the data, as well as the resulting reports and visualisations.
The program was developed in close consultation with Boehringer Ingelheim, who was seeking an integration solution that would enable it to accelerate reporting, streamline regulatory compliance through the creation of audit trails and enhance productivity through faster access to critical data.
The company is now in the process of installing the software in its locations throughout the world and will phase it into production over the next year.
Boehringer Ingelheim also plan to use the software to improve its analytical capabilities, which could help its researchers rapidly assess the viability of new compounds and accelerate the development of new products.
"We believe that Oracle Clinical Data Repository will provide a core platform that will not only help us improve productivity, but will also prepare us to fundamentally transform the way we develop drugs," said Klaus Stern, vice president Medical Data Services, Boehringer Ingelheim.
