Octagon's ViewPoint Supports EU Module 1 Specification
Octagon Research Solutions announced support for recent European Union requirements for electronic Common Technical Document (eCTD) Submissions with the general availability of the following new versions of its eCTD product suite:
- ViewPoint v.3.12.0
- Octagon’s eCTD Viewer, v.2.6.0
- Octagon’s eCTD Validator, v.2.6.0
A key feature of the new releases includes support across all three products for eCTD EU Module 1 Specification, version 1.4.
The new product releases include support for updated attributes, naming conventions and checksum information as detailed in the 1.4 specification. The European Union applies the eCTD Specification in the European region as defined by the ICH M2 Working Group and completes it with the EU Module 1 specification.
“Support for the latest EU specification is critical to Octagon’s global clients who are submitting eCTD applications in the European Union,” noted Kirk Gallion, president, Octagon Research Solutions, Inc. “We are committed to supporting these updates as the industry continues to realize the global benefits of electronic submissions in general and the eCTD in particular.”
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.
