Clinical trial solutions provider Signant Health has announced a new audit trail reviewing and reporting capability for TrialMax, which is the company’s electronic clinical outcome assessment (eCOA) and remote sensor platform.
The enhancements to the platform enable authorised personnel to easily access and explore key audit trail data via interactive reports and dashboards within a few clicks.
The latest features have been added by the company following consultations with users and clients responsible for data management and clinical oversight.
Signant Health noted that the consultation process was carried out to ensure compliance with data integrity guidance and definitions from the EMA, FDA and MHRA.
Other features that are part of the latest enhancements include standardised key performance indicators (KPIs) on data updates and dashboards of the platform feature data visualisations to support the fast identification of key data integrity metrics.
These new capabilities will also provide users with detailed audit trail access for user accounts and login activity on the company’s study portal TrialManager.
The latest update comes as part of a response to the emerging demand from regulatory bodies on life science firms to put quality systems in place for accurate drug evaluation.
Signant Health Product Management senior vice-president Rauha Tulkki-Wilke said: “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.
“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.”
In November last year, Signant Health integrated its eCOA platform TrialMax with ActiGraph’s CentrePoint system.
