The eClinical equation: Part 2 – Bridging connections for innovation

The pharmaceutical industry (Pharma) is at a critical point in its transition to a new model of drug development: making targeted medicines. The blockbuster model has served Pharma well, but it cannot address the challenges involved in predicting the safety and efficacy of new drugs, and developing treatments for patients with specific disease subtypes. If Pharma is to succeed in making such treatments, it needs a new model that is enabled by an integrated electronic infrastructure spanning the research and development (R&D) spectrum.

Our previous paper, "The eClinical equation: Part 1 - Electronic data capture,"¹ describes electronic data capture (EDC), one of the basic components of an eClinical environment. This Part 2 paper addresses how Pharma can build an "interoperable" infrastructure in which disparate sources of information can be aggregated and analyzed.² That, in turn, will enable a better understanding of the clinical data Pharma companies already possesses, incorporate new forms of biomedical knowledge like pharmacogenomics (genetic factors contributing to patient variability in drug response) and unlock the insights that data sources collectively contain.

Some of the pioneering pharmaceutical companies have already started trying to integrate their existing data sources and connect them with information derived from the molecular sciences. The majority are also participating in various consortia to create industrywide data standards, and beginning to collaborate with external organizations. Regulators in the U.S., Europe and Japan are actively encouraging the use of standards to increase efficiency within the development process and to support interoperability across the health care and Pharma industries.

In short, Pharma is increasingly aware that the business model for targeted treatments hinges on the creation of interoperable, inter-organizational data networks. The most successful pharmaceutical companies will be those that act first – both to align their IT strategies with R&D goals, and to build a more agile clinical environment by harnessing the emerging enabling technologies.

To read the full report, download the PDF file at the top of this page.

References
¹ Peachey, Jonathan, Colin Spink and Heather Fraser. "The eClinical equation Part 1 – Electronic data capture." IBM Institute for Business Value. February 2006.

² For the purposes of this study, interoperability is defined as the ability to share and use information across different processes and systems, either within the same organization or among different organizations. Aggregating multiple forms of data from multiple sources enables researchers to detect patterns and anomalies that are difficult or impossible to identify when the data are not connected.