In today’s ACT Brief, we examine who decides what trials measure, how designing for human thinking improves site execution, and how the FDA extended an immunotherapy to a new bladder cancer population.
|Articles|September 1, 2006
- Applied Clinical Trials-09-01-2006
- Volume 0
- Issue 0
eShowcase: ViewPoint 3.6
Tools for Clinical Trials Professionals
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Software provides complete visibility into the regulatory submission process
Octagon Research Solutions, Inc. (Wayne, PA) recently announced an update to its enterprise submission process management solution. Viewpoint 3.6 streamlines the regulatory submission process by affording visibility into the planning and management of the drug submission process and allows users to track, manage, and compile any type of regulatory application.
Viewpoint 3.6 Resource Estimator, Reviewer, and Regulatory Dashboard have been upgraded to provide enhanced workflow estimation, collaboration, and project tracking across the submission life cycle. The new Web-based Reviewer allows content contributors to view and validate their documents in the context of a submission. This, Octagon says, lessens the possibility that clinical trial professionals will miss a submission date or file an incomplete or noncompliant eCTD submission.
ViewPoint 3.6
Octagon Research Solutions, (610) 535-6500,
Articles in this issue
about 20 years ago
The EDC Decisionabout 20 years ago
Training in Pediatric Researchabout 20 years ago
Spotting the "New" Managed Site Networksabout 20 years ago
Drug Development on Rails: Part Twoabout 20 years ago
Research for the Real Worldabout 20 years ago
Building Research Capacity into Drug Developmentabout 20 years ago
eShowcase: PHT eSense Sensorsabout 20 years ago
Australia: The Number One Place for Clinical Trials?about 20 years ago
New Research Models Spur Third-World Effortsabout 20 years ago
eShowcase: TrialSpace DesignerAdvertisement
Related to this article
Clinical trial endpoints define what success looks like, but patients and caregivers are rarely the ones setting that definition, and the gap between what trials measure and what patients actually value is showing up in post-approval evidence, regulatory submissions, and the design rooms where protocols are written.
In Episode 3 of The Human Side of Clinical Trials, hosts Brian S. McGowan, PhD, FACEHP, chief learning officer and co-founder of ArcheMedX, Inc., and Kelly Ritch, chief operating officer of ArcheMedX, Inc., speak with Jason Riis, PhD, CEO and chief behavioral scientist at Behavioralize, about why a well-written protocol doesn’t always translate into consistent execution, and how designing for the way people actually think and learn can reduce site burden and the need for costly unlearning.
In today’s ACT Brief, we examine what it will take to scale EHR-to-EDC connections for real-time trials, how the FDA is reimagining rare disease drug development, and why oncology real-world evidence still faces persistent data barriers.
A new white paper and public engagement process outline the FDA’s commitment to building fit-for-purpose evidentiary standards, stronger patient voice integration, and greater regulatory predictability across rare disease drug development and review.
Real-time clinical trials require standardized digital data capture at the point of care through scaled eSource-EDC-EHR integration, but progress stalls because competing standards lack regulatory enforcement and one-off system integrations cannot scale beyond single studies without industry-wide alignment and legal clarity on data ownership.
In today's ACT Brief, we examine how representation gaps in trials are shaped by structural design decisions, how new partnerships automate data transfer from site systems to sponsor platforms, and how Roche is licensing a novel obesity target from a biotech pioneer.
IgniteData and RealTime Partner to Streamline Clinical Data Transfer From eSource to Sponsor Systems
The partnership gives RealTime's network of more than 3,000 research sites access to the Archer platform for direct, automated data transfer from eSource to any sponsor electronic data capture system or data destination.
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