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Based on initiatives with leading Pharmaceutical companies, this poster addresses the challenges and opportunities in how clinical study data is managed from protocol planning to completion of the clinical study report.

As the number and diversity of clinical studies increases, it tests the ability of organizations to manage key resources during study execution. At the same time, organizations are more dependent on external partners to handle the increased study volumes which ratchets up the complexity of study management further.

In response to Heisenberg’s Uncertainty Principle, Einstein responded “God does not play dice with the universe.” Quite often we launch informatics projects with significant costs and a great deal of uncertainty.

Selecting a new Clinical Trial Management System (CTMS) for an organization holds the promise of better and timelier information sharing, more informed forecasting and planning, and better partner relationships. However, before you leap in it is a good idea to re-examine and re-engineer your current business processes.

As the number, diversity, and complexity of clinical studies increase, sponsor organizations are challenged to coordinate and track key resources during study execution. Sponsors are also reliant on an array of external partners from investigative sites to specialty labs to central lab operations, which are likely to be different organizations across a portfolio of studies.