New features promise expanded capabilities in audit trail monitoring and reporting in the healthcare industry.
FREMONT, CA: Signant Health, the solution provider for the healthcare sector, has released new capabilities that enable audit trail reviewing and reporting processes for its electronic clinical outcome assessment (eCOA) and remote sensor platform, TrialMax®. The new feature will allow designated personnel to access and evaluate data present in audit trails with the help of interactive reports and dashboard controls. The tool works by automatically creating audit trails in real-time when users interact with TrialMax.
The new features that figure in TrialMax have been developed after taking into consideration the opinions of users and clients. “Regulators are looking for eClinical solutions to not simply store an audit history – which is, of course, a vital element – but to make the audit records available in an interrogatable form to enable the integrity of the trial and its data to be assessed by site and sponsor. Simple examples include being able to assess whether patient data entries or procedures occurred before informed consent or detection of an unusual number of data changes by an individual. Providing this data in this way, and tools to explore it, in an up-to-date manner as required by the customer or user is often a non-trivial matter. Our solution surfaces this data in a way that sponsors, and sites can easily explore it and identify any issues early and throughout the study, and to satisfy regulatory requirements to inspect and provide this information in an inspectable manner,“ says Bill Byrom, VP Product Strategy & Innovation, Signant Health.
The need for high-integrity data is on the rise. With the new upgrade, users will be able to conduct quick identification of crucial integrity metrics using dashboard features. Besides, the audit trail review process is set to improve with the new dynamic filtering and interactive graphs. Overall, proving compliance with clinical data with regulatory norms will become frictionless with the recently launched enhancements in TrialMax.
Signant Health has led the way when it comes to offering solutions to help make healthcare participatory and compliant to the most complex regulatory standards. The company focuses on a host of areas, including patient engagement and eConsent. With Signant, many healthcare providers have been able to discover new opportunities and operational efficiencies.