CDISC and OpenClinica Collaborate to Drive Academic Clinical Research Forward

AUSTIN, Texas & WALTHAM, Ma.–(BUSINESS WIRE)–#RWD–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.

ABOUT CDISC

CDISC creates clarity in clinical research by convening a global community to develop and advance data standards of the highest quality. Required by the United States Food and Drug Administration (FDA) and Japan’s Pharmaceuticals and Medical Devices Agency (PMDA), recommended by the China National Medical Products Administration (NMPA) and adopted by the world’s leading research organizations, CDISC standards enable the accessibility, interoperability, and reusability of data. With the help of CDISC standards, the entire research community can maximize the value of data for more efficient and meaningful research that has invaluable impact on global health. CDISC is a 501(c)(3) global nonprofit charitable organization with administrative offices in Austin, Texas, with hundreds of employees, volunteers, and member organizations around the world. https://www.cdisc.org/

ABOUT OpenClinica

OpenClinica transforms healthcare through innovative cloud technology that simplifies running clinical trials. For over 15 years, OpenClinica has been the leading provider for electronic data capture (EDC), eSource, eCOA/ePRO, randomization, RWD integrations, and analytics and reporting solutions. Proven in over 10,000 studies worldwide, the OpenClinica platform is trusted by leading biopharmaceutical companies, contract research organizations, academic institutions, and government agencies. OpenClinica is used across a wide spectrum of clinical research, including drug, device, and diagnostic trials, global health studies involving 200,000 patients, adaptive platform trials, and clinical trials for some of the first gene therapies to be approved for market. Hundreds of small, midsize, and large research organizations leverage OpenClinica to capture better clinical data faster, and to do so in a way that meets the highest standards for security and regulatory compliance (21 CFR Part 11, Annex 11, GDPR, HIPAA). OpenClinica, LLC is headquartered in Waltham, MA. For more information, visit www.openclinica.com.

Contacts

Ann P. White

+1.512.363.5826

awhite@cdisc.org

Jackie Brusch

+1.215.760.4294

jbrusch@openclinica.com