Oversight Management for
Outsourced Clinical Trials
"Risk comes from not knowing"
We Provide Clarity
Oversight Management for Your Outsourced Clinical Trials
Achieving success with outsourced clinical trials presents a unique set of challenges. Sponsors who choose to outsource the execution of their clinical trials remain wholly responsible for the success of the trial, but no longer have direct control of the resources and information needed to exercise that responsibility.
While day-to-day management of an outsourced trial execution is done by a Contract Research Organization (CRO), the Sponsor must still make sure that the trial is delivered on-time and on-budget. The Sponsor remains directly responsible to the FDA for the safety of the trial participants and the quality of the submitted data and results. Until the new drug under trial is successfullyproven and the regulatory agencies have approved its use, 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 is likely to depend on their ability to show predictable and sustainable progress against their trial plans.
The Sponsor needs the clarity that comes from oversight management information about the status, risks and performance of the outsourced trial. That information must be made actionable through timely availability, efficient continuous monitoring, and assisted collaboration with the
extended trial team on any issues raised.
Know Sooner, Decide Faster,
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 Sponsor 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 Sponsor and their 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.
Leading Edge Software Technology
TrialClarity builds on patented software technology that overcomes
the unique challenges of addressing this solution need.
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.