Newsroom

In January, 2010, the CDISC Protocol Representation Group published the final Protocol Representation Model Version 1.0.  The PRM has been described in detail in a number or articles, blogs and in its own documentation.  The intent of this article is to provide simple, basic answers to questions that have arisen recently about the PRM ...

The completion of the Human Genome Project in 2003 has heralded a new era representing a significant rise in the use of Pharmacogenomic (PGx) data in both research and clinical care.  It promises to be an exciting time to pursue greater understanding of molecular pathways and underlying disease risks in certain populations ...

As always, CDISC begins the year with a flurry of activity (do keep an eye on the website for regular updates and news on the standards).  In addition to the CDISC standards themselves, the CDISC Board and Operations Staff also spent the last quarter of the year reviewing the CDISC Strategy and making appropriate changes (see the new CDISC Strategy 2010)...

As Dr. Frank Rockhold assumes the position of Chair, CDISC Board of Directors, this month, CDISC would like to formally congratulate Paula Brown-Stafford on being voted as the new Chair Elect of the CDISC Board.  Paula has more than 20 years experience of working in the Pharmaceutical and CRO industry. She has worked closely with the CDISC standards and has ensured that Quintiles has devoted time and energy to their implementation within the organization ...

The CDISC-AdvaMed Device Team has covered a lot of ground since the last CDISC newsletter update.  As many of you are aware, this project seeks to develop in parallel the CDASH data collection fields, the SDTM submission variables and the associated metadata for basic device clinical studies...

The day saw 53 delegates attend from across UK, Germany, Switzerland and Ireland. There was variety amongst those in attendance in their working disciplines, from Data Managers, Statistical Programmers and Medical Writers. There were also Software Vendors in attendance and also presenting ...

This year’s North American Interchange rounded off a successful year for CDISC events, with the highest ever attendance figures for a CDISC conference. For the first time at a US event, CDISC stepped out of Washington to Baltimore and held their inaugural social event at the National Aquarium (more of this later).

Asked to reflect on 2009 as it comes to a close, I have to admit that it has not been an easy year for most. With the downturn in the global economy, we have all been re-evaluating our expenditures and processes with an eye on being more efficient and cost-effective.

Back in February of this year at the CDISC Intrachange the teams gathered in Washington DC on a cold and wet Tuesday morning for a series of cross-team meetings. We generally start the Intrachange with a plenary meeting that allows everyone to meet and say hi and to permit me and the team leads to set the scene for the coming three days.

CDISC standards are provided to the public at no charge.  This means the funding vital to the on-going development and maintenance of CDISC standards can only continue with your financial support through membership.  If you are already a member, thank you, and if you are not, please consider joining ...

CDISC, the Clinical Data Interchange Standards Consortium is an international standards development organization whose mission is “to develop and support global, platform-independent data standards that enable information system interoperability to improve medical research and related areas of healthcare”.

As members and/or supporters of the Clinical Data Interchange Standards Consortium (CDISC) Global Expert Group, we wish to encourage the advocacy and adoption, along with continued collaborative development, harmonization and support of the CDISC global clinical data standards that facilitate the clinical research process while integrating it into the healthcare arena.