In Search of the Holy Grail - Pharmaceutical Executive

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In Search of the Holy Grail
Chasing ultimate clinical trial efficiency, one small step at a time


Pharmaceutical Executive


When discussing integration (or any new technology for that matter) executives often ask for a quantified return on investment (ROI). This currently remains an open question, and one that P&GP integration teams are not focusing on. Some companies claim that their EDC system saved tens of millions of dollars per year. Others say the new systems are cost-neutral compared to their old paper-based systems. For the time being, P&GP is more concerned with accelerating and simplifying processes, reducing the time to lock each study database, and improving overall study management. Nevertheless, the company does aim, eventually, to identify a set of metrics that offers unequivocal evidence of the financial ROI.

A carefully considered approach to data integration can benefit every stakeholder from the investigator to the pharmaceutical executive. Data integration can reveal new nuances for clinical studies, such as why so many patients fail screening, and pose new questions about the dynamics of current workflows. But P&GP is moving forward cautiously, one step at a time. Great haste in the beginning may not be the best way to reach our ultimate goal: commercializing a drug as quickly as possible. As this example illustrates, many of the benefits of data integration are proving to be greater than the sum of their parts. As we continue to develop the network, we expect further unexpected phenomena to emerge. Throughout the data integration process, we've learned to expect the unexpected, both in terms of challenges and dividends.

Rob Case is global EDC group manager, Procter & Gamble Pharmaceuticals. He can be reached at


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