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Registering and Reporting Trial Data on ClinicalTrials.gov: A Drugmaker’s Compliance Guide

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Congress has started pushing both the FDA and NIH to begin penalizing drug sponsors who do not report on ClinicalTrials.gov.

When the inevitable compliance hammer falls, will YOU be crushed, bruised or completely out of harm’s way?  It all depends on whether you’re in compliance with clinical trial reporting requirements.

If you’re not, you could be looking at $10,000-a-day penalties when you can easily ensure compliance.  Find out how with …

A January 2012 study published in the British Journal of Medicine revealed only 22% of drug trial sponsors actually complied with requirements to report trial results on ClinicalTrials.gov.

Consequently, Congress has started investigations into WHY penalties have not been assessed for non-reporting to ClinicalTrials.gov — and WHY government agencies haven’t stayed on top of the reporting requirements.

The Agencies Coming Under Scrutiny:

The NIH oversees the site and has not implemented the latest phases of the ClinicalTrials.gov mandate to incorporate greater adverse event reporting and expanded trials data into the site.

The FDA is charged with overseeing compliance of the clinical trials reporting requirements.  And, under existing law, they could have charged non-compliant sponsors up to $10,000 a day! 

While the FDA has not actively enforced these requirements, pressure is building and the enforcement hammer could drop on thousands of trials conducted since 2007.  Would yours be one of them?

Take Action Now While There’s Still Time:

Don’t get nailed on this!  Before it happens, sponsors should start to take reporting requirements VERY seriously.  If you’re non-compliant, start today to develop a PLAN to get compliant before you face a $10,000 penalty or worse.

We’ve Prepared This Guide Just for YOU to Help Answer These Important Questions:

  • Which trials must report results?
  • What information must you report?
  • Who is responsible for reporting trial results?
  • What happens if you don’t report results?
  • When can you delay submission?
  • What do you do if your trial isn’t “applicable” and how do you know?
  • How do reporting rules affect patents?

Enforcement appears inevitable, so don’t lull yourself into thinking you’re safe.  Get prepared now!

Our Registering and Reporting Trial Data on ClinicalTrials.gov will help you develop a plan for properly reporting your trials on ClinicalTrials.gov — before enforcement begins.

When you consider the $10k/day price tag for non-compliance, the $377 cost of this invaluable guide is miniscule by comparison. 

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