trialRx® provides real-time insights and benchmarking of your organization’s clinicaltrials.gov compliance supported by a repository that includes over 32 million data points from every field in the 170,000+ clinical trial posted on ClinicalTrials.gov. trialRx® is a flexible solution from Huron Life Sciences, designed and built by experts in life sciences compliance and analytics.
What is trialRx®?
- A clinical trial data disclosure compliance analytics service provided to our clients via a secure, hosted web portal
- Helps our clients understand and address clinical trial disclosure risks efficiently, accurately, and completely
- Powered by a unique, proprietary data analytics and visualization tool that can access every one of the over 32 million unique data points available on clinicaltrials.gov
- Provides real-time insights and enables immediate action to address potential compliance issues
How does trialRx® work?
- trialRx® employs highly sensitive statistical analysis to measure your company’s compliance with respect to NIH, FDAMA (section 113), and FDAAA (section 801) requirements
- Huron works with you to understand your company’s policies and interpretations of regulatory and legal requirements and tailor our statistical models to your specific requirements
- Huron configures the tool to enable complete, automated monitoring in real time of all potential clinicaltrials.gov compliance issues
- Provides an easy-to-digest, interactive, visual platform that overlays public data with internal company data, as necessary, to highlight potential compliance issues. These might include:
- Completeness of clinicaltrials.gov registration and results data postings
- Timeliness of historical and upcoming registration and results posting
- Accuracy of clinicaltrials.gov data, including potential data quality issues
Why act now?
- Clinical trial data disclosure risks have historically been neither monitored nor addressed, but that has begun to change – rapidly – both in the U.S. and in the EU.
- The cost of compliance is negligible compared to potential fines. Life sciences companies typically have at least 50 applicable trials posted at any given time, meaning there is potential for $500,000+ per day in fines for non-compliance (potential fine is $10,000/trial, per day).
- The average trial is missing 1 in 15 of the legally required data elements per trial.
- Congress, CMS, and EMA have noticed, and are taking action.
Benefits of trialRx®
Improved Regulatory Compliance
Our clients have gained a way to understand their overall potential risk exposure on clinicaltrials.gov for every one of their clinical trials, and have built stronger mutual understanding with Clinical Operations personnel of relevant compliance obligations
- One company saw its non-completeness rate drop to less than 1% -- down from over 14% -- within two months of beginning to use trialRx®
Improved Data Quality
Our clients have identified and remediated numerous data quality issues, which were revealed through the configuration process (e.g., lack of universal trial numbers across studies, errant sponsor listings, non-harmonized study conditions).
Improved Business Insights and Operations
Huron custom-configured reports for a client to support clinical trial data transparency outreach via the generation of high-value, ranked target lists of sponsors investigating key tumor types of interest. This enabled the client to focus on outreach efforts in an informed way – rather than on corralling and structuring the limited data extracts available through clinicaltrials.gov.
Huron made the investment so our clients don’t have to. The capability is already built and ready to be customized to meet your unique needs.