Comprehend reveals new solution at DIA 2019, designed for clinical trial process improvement and greater ICH E6(R2) compliance.
Comprehend reveals new solution at DIA 2019, designed for clinical trial process improvement and greater ICH E6(R2) compliance.
REDWOOD CITY, Calif., June 18, 2019 /PRNewswire/ -- Most sponsor companies have relied on outsourcing to support their portfolio needs for decades, yet only 20 percent rate their oversight practices as highly effective. This is just one of the key findings of a study conducted by the Tufts Center for the Study of Drug Development (CSDD).
“Respondents identified many opportunities for oversight improvement,” said Kenneth Getz, principal investigator of the study and an Associate Professor at Tufts CSDD. “These include faster issue identification and resolution, data transparency, real-time communication between sponsors and CROs, and greater senior executive involvement.”
At DIA 2019, Mr. Getz will chair a session on effective CRO oversight, based on the results of the study. The session will include Liz Wool, BSN, and is scheduled for Tuesday, June 25 from 10:30–11:30 a.m. The session will help sponsors learn how to meet important oversight objectives, such as enhanced compliance, reduced risk, and improved study performance.
In response to the new benchmark research on oversight, as well as customer feedback, Comprehend has been developing a new solution called the Oversight Scorecard. This flexible interface provides a quick, comprehensive overview of risk, quality, and performance Indicators across a single study or entire portfolio, so users can improve oversight of studies, sites, and vendors as outlined in ICH E6(R2) guidelines.
“Using a highly configurable algorithm, the Comprehend Oversight Scorecard will enable a flexible approach to risk modeling,” says Dr. Jon Allen, Comprehend’s VP of Product Management. “Users can score sites, studies, countries, and vendors based on metrics they select, for faster, better decision-making.”
The Comprehend Oversight Scorecard will address significant data-related challenges that limit oversight, such as a lack of actionable insights and root-cause analysis details, as well as late and incomplete data.
While the Comprehend Oversight Scorecard is for all levels of management, Dr. Allen says that its intuitive interface “will increase participation among sponsor executives.”
In the Tufts CSDD study, respondents noted that a higher level of senior executive input would positively impact outsourcing practice and oversight effectiveness. “Without the involvement of senior executives, oversight appears to be more reactive and tactical in nature, and sponsors are missing key insights and actions that could lead to higher and more sustained performance,” Getz says.
Comprehend will demonstrate its new Oversight Scorecard at DIA’s 2019 Global Annual Meeting in San Diego, from June 23–27. You can find Comprehend at the conference at Booth 2337.
For more information, contact Nick Pham at 650-521-5449 or 216478@email4pr.com.
About Comprehend
Comprehend provides a suite of cloud applications and consulting services that dramatically improve the clinical trial process. Our solutions deliver actionable risk and performance insights across studies, systems, sites, and vendors. By using elements of our Clinical Intelligence Platform to unify, monitor, and analyze data across all sources, sponsors and CROs alike are able to reduce risk, achieve milestones on time, and stay within budget. As a trusted partner, Comprehend helps speed the time to quality results.
Contact: Nick Pham
650-521-5449
216478@email4pr.com
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SOURCE Comprehend Systems