Generic Industry Challenges:
Expiring patents, drying pipelines, increasing budgets, stringent regulations and cost pressures are some of the challenges faced by the Life Sciences industry. While these are macro challenges, teams responsible for clinical, regulatory and safety for clinical trials, regulatory submissions and patient safety respectively have a totally different set of challenges that they deal on a regular basis.
Data and documents generated during the course of the trials are managed by IT systems that have been either built in house or procured off the shelf. A major challenge that is faced by IT teams in large enterprises is to provide information and intelligence to their business teams that would cross (by integrating information) these siloes and help them make sound business decisions.
SOA based Information Integration:
Imagine a situation where all these systems in the clinical enterprise are integrated and connect seamlessly. The glue that binds all these systems can be a fully Service Oriented Enterprise Service Bus (ESB). Not just that, it should also be standards based. This will reduce the dependency on interfaces between systems in use and future proof the enterprise from replacement, retirement and enhancements to the individual systems. In order to bring visibility to data and documents across the systems there is a need to aggregate data and documents into Clinical Data Repository (CDR) and an Enterprise Electronic Document Management System (EEDMS).
The diagram above depicts a few information systems within the Clinical, Regulatory and Safety areas of Life Sciences R&D. This integration has to be:
- Loosely Coupled (SOA)
- Standards Based (CDISC / HL7)
- Open Architecture (XML, SOAP) and
- Survive system upgrades, replacements and retirements
Some of the advantages with the above mentioned integration would be:
- Integrated Clinical Enterprise Information Systems
- Easier and simpler integrations with partners and third parties
- Adoption of standards
- Integrated data and documents to enable faster decision making
- Faster Time to Market
- Lower Total Cost of Ownership and
- Better ROI