|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

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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

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© putilov_denis - © putilov_denis - stock.adobe.com
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.