Blog

PhUSE is Coming to Boston

August 19, 2010

The OpenCDISC team is pleased to announce our participation in the first ever US based PhUSE Single Day Event (SDE) which will be held in Boston on September 28th, 2010 at the New England Research and Development Center. If you are not familiar with PhUSE, it’s a non-profit organization dedicated to providing a forum for pharmaceutical programmers to share ideas, knowledge, and new technologies relevant to the future direction of our industry.

OpenCDISC Validator 1.1 Released

June 2, 2010

The OpenCDISC team is pleased to announce the availability of OpenCDISC Validator 1.1. 
Download OpenCDISC Validator 1.1 here

What’s New in Version 1.1

The latest release is focused on performance and scalability. The validation engine has been improved and tuned to run up to 3x faster at the minimum recommended hardware configuration. The Validator has also been enhanced to take advantage of multithreading and additional memory available on powerful workstations and server environments to scale to validate the largest studies and datasets. Please refer to OpenCDISC Validator Performance and Scalability Guide for further details.

OpenCDISC at the CDISC Interchange North America

November 4, 2009
We are looking forward to demoing OpenCDISC Validator at the CDISC Interchange in Baltimore next week. Come and see the latest release, including SDTM v3.1.2 support, and more. The demo will be held on Wednesday noon - 7pm at the exhibition area. Also, stop by to meet and chat with the team on Wednesday and Thursday any time at booth 12. CDISC Interchange North America November 9-13, 2009 Baltimore Marriott Waterfront Baltimore, MD

OpenCDISC Validator Goes Beta!

July 27, 2009
Hi everyone, We are happy to announce the release of OpenCDISC Validator Beta. This is a major milestone bringing us another step closer to production. Download OpenCDISC Validator Beta here

What's New in Beta

  • Support for 100% of documented Janus and WebSDM validation rules
  • 10 additional rules contributed by the community
  • Validation checks against define.xml
  • Validation checks against CDISC Terminology
  • New report formats including Excel and CSV, in addition to HTML

OpenCDISC Validator Alpha 2 Released

February 16, 2009
Hi everyone, The Alpha 2 release of the OpenCDISC Validator is now available! Download OpenCDISC Validator Alpha 2 here The latest version introduces a number of new features with most important being the capability to perform cross-dataset validations and lookup validations. The latter allows dataset content to be validated against dictionaries such as MedDRA and LOINC as well as data management and trial management systems. This is made possible by the ability to define rules against data stored in a number of supported database engines and external SAS® XPORT files. Currently supported databases are Oracle, SQL Server, and MySQL.

Janus Compliance with OpenCDISC Validator

November 12, 2008
So your company has decided to submit SDTM datasets to FDA. You have worked tediously to make sure that your datasets comply with SDTM Implementation Guide (SDTMIG). You even validated your datasets with WebSDM. Can you be sure that your data will successfully load into FDA's Janus data warehouse? The short answer is No, as has been demonstrated by the Sanofi-Aventis team in their paper Experiences Submitting CDISC SDTM and Janus Compliant Datasets.