WALTHAM, MA — Mar. 15, 2022 — OpenClinica, the leader in eclinical solutions and clinical trial support (electronic data capture (EDC), ePRO/eCOA, EHR eSource, randomization, and reporting), today announced its 2022 gold membership status with the Clinical Data Interchange Standards Consortium (CDISC).
Members of CDISC include pharmaceutical, biotechnology, academia, government, and technology and service providers in the clinical research industry. All members have an interest in helping CDISC bring clarity to data. In addition, members have access to the CDISC library, library archives, credits to enhance employee learning via online courses, and access to thought leadership programs where trends and insights can be discussed and put into action.
OpenClinica’s partnership with CDISC is another step in its ongoing efforts to grow the organization, its people, and, most importantly, the seamless clinical data management experience that OpenClinica’s customers know and love.
This announcement comes on the heels of OpenClinica’s recent collaboration with CDISC to better understand the barriers among the academic community. Together, CDISC and OpenClinica will implement CDISC standards in Real World Data (RWD) to get a picture of the tools and guidance needed to standardize and leverage RWD. The partnership 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 an invaluable impact on clinical research.
The eCRFs will be available to the academic community in Q1 2022.
“As a gold member, we can increase our reach and overall contributions across the clinical research landscape. Ultimately offering our clients and the industry best-of-breed solutions that produce better data, faster. It’s all part of our goal to enable driving the future of digital clinical trials,” said Andrea Flathers, Senior Director of Client Services at OpenClinica.
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/
OpenClinica is transforming healthcare through innovative cloud technology that simplifies running clinical trials. 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 on OpenClinica’s solutions for electronic data capture (EDC), eSource, ePRO, randomization, and analytics and reporting – visit www.openclinica.com.
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