eClinical Software: January 2009

New Version Open Source EDC Software

Features include study monitoring and query management tools

Akaza Research (Cambridge, MA) announced the availability of OpenClinica 2.5, its open source clinical trials software for the clinical trials industry.

OpenClinica 2.5 Open for Business

The new release features new study monitoring and query management tools and reports; import of data from external sources; enhanced eCRF features, including scoring, multivariate edit checks, and rules; user roles for monitors and data managers; electronic signature capabilities; improved auditing and logging capabilities; and simpler CRF upload.

The new version has also been translated into three additional languages: French, Italian, and Portuguese. It also features support for the Oracle database. It's available for free download at www.openclinica.org.

Akaza Research, (617) 621-8585, www.akazaresearch.com

eClinical Product Suite Enhanced

Includes tracking for metrics on investigative site performance

DATATRAK (Mayfield Heights, OH) offers the next release of its eClinical Product suite for global clinical trials. Detailed clinical trial information can be found in this new version. For example, with this version of DATATRAK eClinical, as long as this platform is consistently used, clinical trial sponsors will be able to characterize the historic quality of a research site before the clinical trial is started, based on investigative site performance.

OpenClinica 2.5 Open for Business

In addition, the Query Manager now filters on Data Point Changes to see if team members have responded to queries. Standard reporting additions have been made to the study homepage to include time averages for various study activities, form counts, breakdown of data point status, and more. It also includes Japanese/Kanji-character translation.

DATATRAK, (888) 677-3282, www.datatrak.net

Preconfigured eCase Report Forms Added

CDISC standard applied to forms for EDC/CDM product

Medidata Solutions (New York, NY) has included preconfigured and validated electronic case report forms (eCRFs) that comply with the CDASH Version 1.0 standard for collection of clinical safety data. These eCRFs are mapped to SDTM-compliant reports.

Used in conjunction with Medidata's Rave EDC and CDM product's study design and reporting capabilities, will enable sponsors to jumpstart EDC set-up, tailor studies to specific needs more quickly and efficiently, and reduce the risk and complexity involved in adopting a standards-based approach to study build and submissions.

Medidata Solutions, (877) 511-4200, www.mdsol.com