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CDISC and OpenClinica Collaborate to Drive Academic Clinical Research Forward

Wednesday, October 20, 2021

CDISC announced that it is collaborating with OpenClinica to improve data collection in clinical studies conducted by academic institutions and researchers with the goal of driving research forward.

The collaboration came about as a result of CDISC’s efforts to better understand the barriers among the academic community to implementing CDISC standards in Real World Data (RWD) and get a picture of the tools and guidance needed to help to standardize and leverage RWD. Community feedback included the need for robust software tooling to enable efficient data collection.

In response, CDISC will instantiate electronic Case Report Forms (eCRFs) from its eCRF Portal into OpenClinica’s Electronic Data Capture (EDC) content library so that academic researchers can leverage the eCRFs to easily adopt CDISC Standards while capturing data for their studies. Implementing CDISC standards allows data to be structured effectively, leaving academics more time to focus on discoveries that will have invaluable impact on clinical research.

“Real world data plays an increasingly important role in clinical research and health care decision making,” said Dave Evans, President and CEO, CDISC. “This collaboration will allow the academic community to reap the many benefits of connecting RWD to CDISC standards, including improvements in data sharing, cross-study analysis, and meta-analysis of data.”

“Our sizable community of academic researchers are going to benefit in many ways from these reusble case report forms embedded with CDISC-standard metadata. These expert-defined forms provide structure for high-quality clinical research data. Making them available in the OpenClinica form library enables best practices and saves time for our researchers. We are proud to partner with CDISC on these implementation-ready case report forms,” said Cal Collins, CEO of OpenClinica.

The eCRFs will be available to the academic community in Q1 2022.

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