|Articles|November 1, 2006

Applied Clinical Trials

  • Applied Clinical Trials-11-01-2006
  • Volume 0
  • Issue 0

eShowcase: Clintrace 4.1

Release takes adverse event reporting to a new level, complies with FDA's new rules

Release takes adverse event reporting to a new level, complies with FDA's new rules

Phase Forward Inc.(Waltham, MA) released version 4.1 of its adverse event reporting and regulatory compliance solution software, Clintrace. A result of Clintrace's integration with Cognos Inc.'s ReportNet software, Clintrace now has additional adverse event and operational information reporting capabilities, as well as enhanced data analysis capabilities. Clintrace 4.1 also features compliance with FDA's MedWatch 3500A form, the new online mechanism for mandatory reporting of serious adverse events, potential and actual medical product errors, and product quality problems involving FDA-regulated drugs, devices, biologics, and dietary supplements.

Clintrace 4.1

The integration with Cognos ReportNet, which offers a single authoring environment for creating reports to improve decision making, will let Clintrace users build their own reports without IT involvement. This, the company says, will afford added flexibility and cost- and time-saving opportunities.

Phase Forward Inc., (888) 703-1122, www.phaseforward.com

Articles in this issue

almost 20 years ago

Building Your Clinical IT Team

almost 20 years ago

Experts Urge Major Overhaul at FDA

almost 20 years ago

Recruitment & Consent in India

almost 20 years ago

eShowcase: iPlan Flow

almost 20 years ago

Meet the EAB: Somesh Nigam

almost 20 years ago

Merging eHR & EDC Conference

almost 20 years ago

eShowcase: PharmaReady V3.0

Related to this article

© C Davids/peopleimages.com - © C Davids/peopleimages.com - stock.adobe.com
The clinical research industry talks about patient-centeredness constantly but embeds it too late, too narrowly, and without clear ownership, and the cost shows up in enrollment failures, protocol deviations, and outcomes that don't reflect what patients actually care about.
The Human Side of Clinical Trials: How Measuring Readiness at Training Predicts Trial Risk Before It Shows Up in the Data
This episode of The Human Side of Clinical Trials, hosted by Brian S. McGowan, PhD, FACEHP, chief learning officer and co-founder of ArcheMedX, Inc., and Kelly Ritch, chief operating officer of ArcheMedX, Inc., explores why training completion metrics like attendance and quiz scores fail to capture true study readiness, and how measuring both competence and confidence can reveal trial risks before enrollment even begins.