Make sure the trials associated with your business and your business prospects are following the rules.
In the past year the HHS and NIH have made a push to make stronger enforcements around clinical trial compliance. Yet only 29.16% of completed studies in the US have a properly maintained study protocol registered with ClinicalTrials.gov.
TrialCompliance enables users to see and export trial compliance data in a number of ways:
- Look at trial compliance by entering a specific NCT number.
- Filter for compliance rate by sponsor
- Identify compliance rates by study status and geography
- Export all available data into an Excel workbook
How it Works
On a weekly basis we download all of the data from over 230,000 trials CT.g, clean it for errors, categorize much of the information, then update our filters and visualizations.
All BrackenData products come standard with the ability to filter our database on fields such as Phase, Study Start Date, Country of Origin, Therapeutic Area, Study Status, Trial Site Country, Trial Site City, Phase, Enrollment Numbers, Keywords, Title, Associated Contact Information, and Sponsor Name.
TrialCompliance takes this a step further by looking at how Protocol structure and updates align with FDA guidelines.
For example, Phase II-IV trials require obtaining an NCT number within 21 days of enrolling the first subject in a study. Another example, results must be posted within 12 months of a registered trial completion date. These are just two factors our system is able to look at to produce charts and tables containing trial data and compliance rates.
There are two views that provide different ways to splice the data. In Compliance View a user can enter a specific NCT ID to check a study's compliance, or filter by study status and geography. In Sponsor View you can enter a sponsor name, identify how many trials by the sponsor are in the database, how many of these are FDA compliant, and look at overall compliance rate.
In both views a user has the option to export all available data to Microsoft Excel for further analysis.
Who Are Our Users?
- Academic and medical centers with funding contingent on protocol compliance
- Pharmaceutical executives
- CROs and software teams selling regulatorty services
- Private equity firms and research analysts
Signup for a demonstration of TrialCompliance and we’ll set you up with a complimentary 2-week license.
Licenses start at $3,500 per year.