spacer
home > news > detailed info
INDUSTRY NEWS AND PRESS RELEASES

Signant Health Enhances Audit Trail Reporting Capabilities in TrialMax® to Improve eCOA Data Integrity Monitoring

Signant Health

The new audit features comply with the latest global regulatory guidelines for report design

PHILADELPHIA, PA – 29th January, 2020: Signant Health has announced new audit trail reviewing and reporting functionality today for its electronic clinical outcome assessment (eCOA) and remote sensor platform, TrialMax®.This new functionality enables authorized personnel to simply and quickly access and explore key audit trail data through interactive reports and dashboards in just a few clicks. The efficiencies are realized through TrialMax’s ability to track user actions and inputs in real-time, automatically creating a behind the scenes audit trail as users interact with the tool, and through leveraging Signant Health’s enterprise analytics platform.

Signant Health developed TrialMax’s latest audit features in consultation with users and clients responsible for clinical oversight and data management in order to ensure compliance with data integrity guidance and definitions from the FDA, EMA and MHRA. These latest features provide TrialMax® users with:

• Standardized key performance indicators (KPIs) on data updates, removals and original entries.
• Dashboards featuring data visualizations to support the fast identification of key data integrity metrics.
• Dynamic filtering and interactive graphs to analyze the data and reconstruct the course of events as a part of the audit trail review process.
• The ability to demonstrate clinical data comply with regulatory ALCOA (attributable, legible, contemporaneous, original and accurate) data integrity principles.
• Detailed audit trail access for user accounts, roles and login activity on Signant Health’s study portal, TrialManager®.

This update comes in response to the ever-increasing demand from regulatory bodies on life science companies to put quality systems in place to ensure generation of high-integrity data for accurate drug evaluation. Enabling the detailed inspection of audit trail data is a regulatory compliance requirement, with audit trail deficiencies cited in a growing number of regulatory inspections.

“The proliferation of home-based remote sensors, eCOA, and other sources of patient data have increased the volume and variety of data captured in today’s trials, making data integrity monitoring more cumbersome than ever before”, comments Rauha Tulkki-Wilke, Senior Vice President, Product Management, Signant Health. “The TrialMax platform now offers enhanced audit trail reporting capabilities that enable sponsors and sites to fulfill regulatory and GCP requirements by inspecting the underlying audit history to ensure data integrity – made easy through the interactive reporting tools provided through TrialMax. This is a critical element in establishing the traceability and reliability of an electronic record.”

To learn more about Signant Health’s solutions for eCOA, eConsent, Patient Engagement, IRT, Clinical Supply Management, and Endpoint Quality scientific and data support services, visit signanthealth.com.

About Signant Health
The best technology succeeds in the background. Signant Health (formerly CRF Health and Bracket) provides solutions that simplify every step of the patient journey to make it easier for people to participate in, and for sites and study teams to run, clinical trials. Signant unites eCOA, eConsent, Patient Engagement, IRT, Clinical Supplies and Endpoint Quality into the industry’s most comprehensive patient-centric suite – an evolution built on more than 20 years of proven clinical research technology. Our intense focus on the patient experience, deep therapeutic area expertise and global operational scale enable hundreds of sponsors and CROs (including all Top 20 pharma) to extend the reach of drug development, expand patient opportunities and improve data quality – helping them bring life-changing therapies to our families and communities around the world. Take a significant step toward patient-centricity at signanthealth.com.

CRF Health and Bracket are now Signant Health.

Contact: media@signanthealth.com, +1 267.498.2350

phone +1 267 498 2300
email media@signanthealth.com
web https://signanthealth.com/
email 4000 Chemical Road Suite 300 Plymouth Meeting, PA 19462
 
Print this page
Send to a friend
   
spacer
News and Press Releases

High Throughput Analytics Herald a Paradigm Shift in the Development of Biopharmaceuticals

Heilbronn/Dortmund August 2019: Biopharmaceuticals have revolutionized therapies of various diseases. In particular with regard to chronical and/or severe clinical conditions like multiple sclerosis, rheumatoid arthritis or cancer they are considered the future of treatment. Also economically biological drugs are on their way up: The global biopharmaceuticals market is anticipated to reach about 400 billion USD by 2025. Which strategic alignment will help best to fill a successful pipeline?
More info >>


White Papers

Analysis of Biopharmaceuticals to Conform to ICHQ6B

RSSL

Worldwide, the pharmaceuticals market is anticipated to grow from more than USD 782 billion in 2011 to approach a value of just over USD 971 billion by the end of 2016, registering a CAGR of over 24%. In 2010 the average medicines expenditure per person within the UK was £271, and this is expected to increase with the ageing population. A significant and increasing proportion of these sales are protein-based biotherapeutics or biomolecules. Currently, these account for 19% of the total market, and are growing at twice the rate of traditional small molecule pharmaceuticals. It is predicted that close to 50% of the top 100 pharmaceutical products will be biomolecules by 2016. By far the largest segment of the biopharmaceutical market is the monoclonal antibody (MAb) with an estimated share of 25.6%, which corresponds to USD 51.1 billion.
More info >>

Industry Events

Evolution Summit

4-7 May 2020, The Ritz Carlton, Fort Lauderdale, FL

The 22nd Evolution Summit is the premium forum bringing leading drug development executives and solution providers together. As an invitation-only event, taking place behind closed doors, the Summit offers an intimate environment for a focused discussion of key new drivers shaping drug development.
More info >>

 
©2000-2011 Samedan Ltd.
Add to favourites

Print this page

Send to a friend
Privacy statement