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The FDA is Knocking at your Door – Are you Ready for an FDA Site Inspection?

By January 31, 2017March 9th, 2022No Comments

Are you ready for an FDA site inspection?

You may have heard that CluePoints signed an agreement with the FDA. This Cooperative Research and Development Agreement(CRADA) explores a data-driven approach to selecting sites which exhibit data anomalies indicative of fraud, misconduct or sloppiness. This shouldn’t come as a shock, since The FDA has been very vocal about their stance on Risk-Based Monitoring1

In 2015, The FDA issued 17,2322 warning letters, that’s a whopping 92% increase on letters sent out in 2014. The statistics reinforce the fact that investigators are interrogating sponsor’s data and protocols more thoroughly than ever before. Now, picture this, The FDA is knocking at your door – can you say that you’re 100% confident that your clinical trial data meets the recommended standard set out by the FDA? If not, it’s time to take preventative action.

CluePoints’ RADAR™ service enables sponsors to achieve a data-driven understanding of risks upon which to base high-impact site inspection readiness activities. Our Data Analysts will undertake a comprehensive statistical analysis of trial data using CluePoints’ software to provide sponsors a ranked list of the most anomalous sites, highlighting the areas of risk across site and patient data.

1 FDA Guidance for Industry, Oversight of Clinical Investigations – A Risk-Based Approach to  Monitoring

2 FDA Enforcement Statistics Summary Fiscal Year 2015

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Patrick Hughes

Patrick holds a Marketing degree from the University of Newcastle-upon-Tyne, UK, and a post-graduate Marketing diploma in Business-to-Business Marketing Strategy from Northwestern University - Kellogg School of Management, Chicago, Illinois. Responsible for leading global sales, product, marketing, operational and technical teams throughout his career, Patrick is a Senior Executive with over eighteen years international commercial experience within life sciences, healthcare and telecommunications. In the past, Patrick consulted on corporate and commercial strategy for various life sciences companies and was responsible for successfully positioning ClinPhone as the leading Clinical Technology Organization during his 10-year tenure with the company.