"Risk comes from not knowing"
Oversight Management for Your Outsourced Clinical Trials
Achieving success with complex clinical trials presents a
unique set of information technology challenges.
Sponsors increasingly choose to outsource the execution of their clinical trials to experienced Contract Research Organizations (CROs), many of whom then outsource portions of the trial's execution to others. Each of these outsourced resources collects data in information systems optimized for
only a portion of the trial. As a result, the information needed to effectively manage the whole trial is held in a large number of
non-interoperable data "silos".
Those responsible for the management
of a clinical trial must ensure adherence to the trial protocol by a globally dispersed set of resources, and that the trial is
completed on-time and on-budget.
They need near realtime access
to the disparate sources of trial data,
and they need software to turn that data into
actionable information on the
the status, risks, and performance of a trial underway.
Until the trial is completed successfully, the Sponsor cannot begin to realize a return on the significant financial and time-investment it has made. For some Sponsors, their ability to attract the funds required to conduct and complete a trial often depends on showing predictable and sustainable progress against their trial plans.
Clarity comes from having up-to-date oversight management information about the trial underway - the result of efficient continuous monitoring of trial data collected for
signals indicating trends or events requiring attention, and
assisted collaboration between the
extended clinical trial team to resolve issues detected.
Those who manage and execute
ever more complex trials need
TrialClarity derives, on a near real-time basis, key risk and performance indicators from the clinical and operational data already collected during a trial. TrialClarity monitors these indicators and notifies the trial team of trends and alert conditions that may require corrective action. Data visualization and analytics allow the clinical trial management team to explore the root causes of deviations from plan, and an issues management feature facilitates collaborative communications among the trial team members to resolve.
Using TrialClarity, the clinical trial team are able to address deviations from a plan with a positive impact on time to completion and the cost of getting a new drug to market. TrialClarity can save millions of dollars per trial and help to ensure successful completion in closer to the planned timeline.
TrialClarity builds on our patented EdgeNode Digital Health Solutions Platform software technology. The EdgeNode platform is designed to access information from disparate sources, detect signals in the data that indicate trends demanding attention, and facilitate action by quickly sharing the insight and coordinating a response.
EdgeNode utilizes a distributed "nodal processing" architecture that supports data privacy, security, and integrity for sensitive health data, semantic interoperability between different source systems, and autonomous processes that work together to encourage efficiency.
TrialClarity builds on EdgeNode platform with additional technology needed to deliver our unique Oversight Management Solution.
TrialClarity’s EventChain™ software technology uses Blockchain-like capabilities to create and keep a secure, auditable record of the trial’s monitored progress, of each issue raised, and of the actions taken by the extended trial team to resolve them. An EventChain consists of TransactionObjects.
TrialClarity’s TransactionObjects™ provide a unique way to store all of the information related to a specific action or step that is required in a process. This patented data structure accommodates the wide range of data sources from existing clinical trial systems as well as many ancillary information sources (e.g., email messages, spreadsheets, etc.). The result supports a complete record of the timeline of events, facilitates collaboration between team members, enables a wide range of advanced analytics, and facilitates application of AI concepts to the oversight process.
TrialClarity's ActionAssist™ technology facilitates users in taking collaborative action to investigate and implement corrective action plans by augmenting user-specified rules with AI-based learning. ActionAssist acts as an independent agent to ensure that prescribed steps are followed in a timely fashion and that the extended outsourced trial organization is responsive to Sponsor requests.