Data management Data is king
The advent of dedicated software has made it easier to keep track of the large volume of information involved in running a clinical trial. Yet the multiplicity of requirements and stakeholders means there are still challenges, not least of integration. Kim Thomas talks to Erin Pennington, director with the Huron Consulting Group, and Raymond Nomizu, CEO of start-up Clinical Research IO, to discover how research sites can maximise the benefits of their software investments.
ites that conduct clinical research trials have to manage multiple relationships, including those with patients, the patients’ health care providers, suppliers, the regulator, the Institutional Review Board (IRB) and the sponsor. Patient details, including communications, need to be stored, appointments need to be scheduled, tasks for staff have to be allocated, protocols need to be managed, interactions with the IRB must be tracked and all billable work accurately noted. Finally, of course, the clinical trial data itself has to be captured.
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Accurate, consistent and accessible Given this complexity, it can be hard to make sure that data is accurate, consistent and easy to access. Traditionally, sites have used multiple spreadsheets to keep track of data, but as well as being unwieldy
Clinical Trials Insight /
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to use, they can lead to information being out-of- date, inconsistent, or inaccurate. In the past decade, however, sites have begun replacing spreadsheets with systems that help them manage trial data more effectively and efficiently.
The most significant development is the clinical trial management system (CTMS) – cloud-based software that enables a research site to store information relating to the running of the study (in particular, recruiting patients, scheduling and financial management) in one place, creating a single version of the truth and avoiding duplication and inconsistencies. “They allow clients or organisations to get a profile of their full portfolio,” says Erin Pennington, director at Huron Consulting Group. “They can see their protocols, and track the lifecycles of those protocols, in those subjects, through the trial.”
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