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Clinical Trial Registration Requirements

 
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Clinical Trials Registration Requirements Overview

The Bracken Group (TBG), an established team of seasoned industry professionals, shares its views on the FDA’s proposed guidance for the implementation of penalties for non-compliance with existing clinical study results reporting obligations.  TBG proposes a solution that allows clinical trial sponsors to verify that reporting requirements have been met.

 
 

Compliance with ClinicalTrials.gov study results registration requirements

In September 2018, the FDA released a draft guidance which proposed civil money penalties for non-compliance with the submission of clinical trial results for the inclusion in ClinicalTrials.gov

TBG responded to the draft guidance giving their perspective on the proposed penalties and how clinical trial sponsors can ensure compliance with these requirements.

 
 

TrialCompliance Lite: Our tool, keeping your trials in compliance.

Bracken Data’s TrialCompliance Lite provides a fast and easy way to ensure your data in ClinicalTrials.gov is compliant with all current requirements. In three easy steps you can determine if your company's trial is compliant or not.

  • Simply enter the NCT number of a trial
  • Our system checks the trial criteria against FDA guidelines
  • TrialCompliance Lite tells you if the trial is compliant or non-compliant
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TBG’s seasoned industry professionals can ensure that your team has a thorough understanding of the proposed guidance keeping your trials and their results in compliance. Our depth of experience with the FDA from IND and NDA filings to meeting preparation and attendance, will set you up for success.