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: TrialSpace Designer
Tools for Clinical Trials Professionals
Advertisement
Package integrates smoothly into existing business enterprise software formats
Fast Track Systems Inc. (Conshohocken, PA) has a new enterprise solution for advancing the clinical development process. According to Fast Track Systems, TrialSpace Designer improves quality by ensuring protocol consistency and accuracy, and eliminates operational ambiguities at the trial design stage.
The solution is tailored to a life science company's specific therapeutic areas to adhere to individual corporate processes, SOPs, and standard text, plus it incorporates existing Word templates. With TrialSpace Designer, clinical trial professionals have access to indication-specific industry benchmark data on procedures and costs from the company's proprietary databases. Fast Track Systems says that the package delivers better operational efficiency with faster trial startup and completion and reduces avoidable operational costs. Among other benefits are quicker and cleaner trial summations for regulatory submissions and shorter trial timelines.
TrialSpace Designer
Fast Track Systems Inc., (215) 358-1400,
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: ViewPoint 3.6about 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 EffortsAdvertisement
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.
Advertisement
Advertisement
Trending on Applied Clinical Trials Online
1
Real-Time Clinical Trials Depend on a Scalable EHR-to-EDC Connection
2
FDA Launches Rare Disease Framework Initiative to Reimagine Drug Development for Small Patient Populations
3
The Human Side of Clinical Trials: Why Fuzzy Mental Models Undermine Clinical Trial Execution
4
Endpoints That Reflect What Patients Actually Value: Who Decides What Counts as Trial Success
5