CDISC Teams Up with Microsoft to Develop Open-Source Software for the Clinical Research Community

CDISC is teaming up with Microsoft to develop the CDISC Open Rules Engine (CORE), open-source software that executes machine-readable CDISC Conformance Rules. The global clinical research community will be able to leverage the CORE software to test study data for conformance to CDISC standards as well as regulatory and sponsor-specific conformance rule sets.

CDISC Conformance Rules as well as regulatory agency rules provide a critical quality check in ensuring study data conform to CDISC standards. An emerging industry best practice is to use Conformance Rules on an ongoing basis, throughout the study, to keep the data as close to submission ready as possible and to ensure quality in all data exchange scenarios. The free and open, Microsoft Azure-based CORE will execute Conformance Rules retrieved from the CDISC Library against standardized clinical research data and produce a report detailing the findings, which will allow researchers to receive, process, and review study data more efficiently and effectively.

"We are excited to work with Microsoft on another important initiative that extends our current work in support of standards-based process automation," said Sam Hume, CDISC VP, Data Science. "We look forward to building a community around CORE that will collaborate to create new innovative features and solutions."

"Microsoft is pleased to expand our work with CDISC to build the next generation CDISC Open Source Rules Engine to support Pharma Industry's digital transformation goals and ultimately accelerate time to market for life saving therapies." - Patty Obermaier, VP of Health and Life Sciences, Microsoft US.

To support and grow a community of open-source software developers, CDISC has initiated the CDISC Open Source Alliance (COSA). Several CDISC member organizations as well as individual developers have already committed to participate in COSA. Microsoft will provide ongoing guidance. Once released, CORE will become a COSA project supported by a global team of open-source developers and CDISC. A key component of COSA is community development.

CDISC collaborated with Microsoft on the Azure-based CDISC Library and CDISC 360, two projects that support standards-based process automation throughout the clinical research data lifecycle.

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.

Most Popular Now

Waiting Times for Medical Admissions Red…

Clinicians at Bolton NHS Foundation Trust have dramatically reduced patient waiting times, decreased hospital length of stay and improved patient safety after developing an electronic acute medical list solution to manage patient referrals.  The configuration was initially set-up to track referrals and admissions...

AI Algorithm Solves Structural Biology C…

Determining the 3D shapes of biological molecules is one of the hardest problems in modern biology and medical discovery. Companies and research institutions often spend millions of dollars to determine...

Accenture HealthTech Innovation Challeng…

Accenture (NYSE: ACN) has named eight companies as finalists in the Accenture HealthTech Innovation Challenge, which brings together leading-edge startups with prominent health companies to tackle some of North America's...

Researchers Use AI to Predict which COVI…

Researchers at Case Western Reserve University have developed an online tool to help medical staff quickly determine which COVID-19 patients will need help breathing with a ventilator. The tool, developed through...

Clinerion Patent for Technology Underpin…

The new Clinerion patent underpins any medical EHR database infrastructure that incorporates a hybrid model of cloud-and-local server node installations at individual hospitals, as well as any method for search...

Data MATRIX Introduces an AI-Operated Pa…

Data MATRIX, a sole Real-World Evidence solutions provider in Russia, has presented a predictive analytics tool for estimating patient survival based on Real-World Data. An important feature of the presented tool for...

Scientists Develop AI to Predict the Suc…

A study in which machine-learning models were trained to assess over 1 million companies has shown that artificial intelligence (AI) can accurately determine whether a startup firm will fail or...

Bittium Expands Its Minority Holdings in…

Bittium Biosignals Ltd, a subsidiary of Bittium Corporation, and British ECG service provider, Technomed Limited, have today signed an agreement under which Bittium will purchase a 25 percent stake in...

A Game Changer: Virtual Reality Reduces …

It isn’t a matter of one needle puncture. Many children coming through the doors of Children's Hospital Los Angeles are seen for chronic conditions and often require frequent visits. Painful...

Open Call HORIZON-HLTH-2022-IND-13-04: S…

This topic aims at supporting activities that are enabling or contributing to one or several expected impacts of destination 6 "Maintaining an innovative, sustainable and globally competitive health industry". To...

Ranking Apps on Privacy

The last thing you want to do when installing a new, free app on your phone is to scroll through pages of information on what kind of access to your...