The new audit features comply with the latest global regulatory guidelines for report design
PHILADELPHIA, PA – January 29, 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.
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