There are a few pre-competitive projects that come to mind. These are the CDISC, Transcelerate Biopharma and PhUSE. CDISC is a global, non-profit charitable organization that develops data standards to streamline clinical research and enable connections to healthcare. It has been a key Standards Development Organization (SDO) in the Pharmaceutical Industry for over 20 years and provides an evolving set of standards to support the consistent definition, collection, tabulation, analysis, and exchange of clinical trial data, ultimately across all disease areas in which clinical research is being conducted.
Since Q4 2016 the so called 'submission data standards models' provided by CDISC (the Study Data Tabulation Model (SDTM) and the Analysis Data Model (ADaM)) became mandated for regulatory submissions by the FDA in the U.S. and by the PMDA in Japan. i.e. all clinical trial data submitted by trial sponsor organizations as part of an electronic submission has to adhere to these standards.
TransCelerate BioPharma Inc. is a non-profit organization with a mission to collaborate across the biopharmaceutical research and development community to identify, prioritize, design and facilitate the implementation of solutions to drive efficient, effective and high-quality delivery of new medicines, improving the health of people around the world.
Since its launch in 2012 it prioritized clinical data standards as an area it would invest, partnering very closely with CDISC to advance the creation of CDISC SHARE - an electronic library to help CDISC manage the lifecycle of CDISC standards and deploy them to industry in machine-readable formats thereby accelerating their seamless adoption. Transcelerate Biopharma invested pharmaceutical industry financial and human resources provided by its sponsor companies, into the extension of CDISC standards across multiple disease areas. Disease areas upon which to prioritize are agreed upon by the Coalition For Accelerating Standards & Therapies (CFAST) - a collaborative effort between CDISC and the Critical Path Institute that prioritizes based on input from the FDA, NCI, and Transcelerate.
PhUSE is an independent, not-for-profit organisation run by volunteers. It is a society with a membership exceeding 8,000, across more than 30 countries worldwide and has become the industry voice to regulatory agencies and standards organisations such as the FDA, EMA & CDISC.
PhUSE runs an annual 'PhUSE - FDA Computational Science Symposium' which brings together FDA representatives and pharmaceutical industry experts tasked with driving the adoption of CDISC standards into their own organizations. The PhUSE community has become an important voice in the industry in this space, and it continues to focus on delivering tangible solutions that support CDISC adoption e.g. it developed a "reviewer's guide" which has become a key document in the exchange of clinical data from a trial sponsor to the FDA.