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Clinical trial oversight management for improved clarity, control, and collaboration.
Completing a clinical trial is a complicated and intricate process that usually spans years. In addition to the outsourced CROs’ own personnel, they bring in subcontracted third parties, such as clinical sites, labs, specialty diagnostic centers, and consultants to provide all the resources needed to conduct the trial. These resources are typically geographically dispersed.
This creates a lost opportunity to identify and correct issues that can lead to significant increases in trial costs, delays, and even failure of trials.
Existing data systems in use today are designed to collect and process the clinical information that is required to prove the efficacy and safety of the drug candidate. They do an excellent job of collecting, storing, and organizing this data for the FDA New Drug Application (NDA) and other regulatory submissions. However, they are not designed to provide those managing the trial with the types of information they need, and the data collected by these existing products tends to stay in their separate silos with little support for true interoperability. As a result, the information needed by those managing a trial is difficult to obtain and often arrives too late to enable corrective action.
TrialClarity is a unique software product that supports the management of clinical trials with computer-assisted analysis of the clinical data being collected for the trial, utilizing artificial intelligence (AI) and machine learning (ML).
With TrialClarity’s powerful technology, the management team is provided with near real-time actionable information and insight into the state of their trial, along with the tools to investigate and take necessary corrective action.
TrialClarity brings the trial management team greater clarity, increased control, and improved response. Additionally, it can help improve response to regulator queries and thereby aide in the successful regulatory approval of an NDA.
TrialClarity significantly improves on-plan, on-time, on-budget completion of a clinical trial, and in doing so delivers significant value to the sponsor of the trial.