eClinical Software: January 2009
Applied Clinical Trials
The latest eClinical software in the clinical trials industry.
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
Including Women of Childbearing Age in Clinical Research
March 26th 2024In recognition of International Women's Month, we're featuring this recent talk between Associate Editor Miranda Schmalfuhs and Marie Teil, Global Head of UCB’s Women of Childbearing Age Program. They speak about the specific challenges women with chronic illnesses face when accessing appropriate treatment and participating in clinical trials, UCB's Women of Childbearing Age Program and it’s most successful strategies, and much more.
Improving Engagement While Maintaining Data Integrity & Validity
March 19th 2024In recognition of Women's Health Month, we're featuring this recent talk between Associate Editor Miranda Schmalfuhs and uMotif's Chief Product Officer, Julia Lakeland, discuss new technologies improving patient engagement and reducing the emotional and logistical burdens of participation, ethical considerations that should be addressed when implementing those technologies, while ensuring patient privacy, and much more.
FDA Grants Ziftomenib with Breakthrough Therapy Designation for NPM1-Mutant Acute Myeloid Leukemia
April 23rd 2024Data from the Phase Ib portion of the KOMET-001 trial showed that the once-daily oral treatment may provide a substantial improvement over available therapies for relapsed/refractory NPM1-mutant acute myeloid leukemia.
