Applied Clinical Trials
The latest eClinical software in the clinical trials industry.
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
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
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
Behind the Buzz: Why Clinical Research Leaders Flock to SCOPE Summit
February 7th 2025In this episode, we meet with Micah Lieberman, Executive Conference Director for SCOPE Summit (Summit for Clinical Ops Executives) at Cambridge Innovation Institute. We will dive deep into the critical role of collaboration within the clinical research ecosystem. How do we bring together diverse stakeholders—sponsors, CROs, clinical trial tech innovators, suppliers, patients, sites, advocacy organizations, investors, and non-profits—to share best practices in trial design, program planning, innovation, and clinical operations? We’ll explore why it’s vital for thought leaders to step beyond their own organizations and learn from others, exchanging ideas that drive advancements in clinical research. Additionally, we’ll discuss the pivotal role of scientific conferences like SCOPE Summit in fostering these essential connections and collaborations, helping shape the future of clinical trials. Join us as we uncover how collective wisdom and cross-industry partnerships are transforming the landscape of clinical research.
Reaching Diverse Patient Populations With Personalized Treatment Methods
January 20th 2025Daejin Abidoye, head of solid tumors, oncology development, AbbVie, discusses a number of topics around diversity in clinical research including industry’s greatest challenges in reaching diverse patient populations, personalized treatment methods, recruitment strategies, and more.