Monthly Archives

January 2017

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

By | Blog, News, Site Inspection Readiness | No 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.

Download CluePoints’ RADAR™ data sheet to learn how we can help you identify clinical sites that may be selected for inspection.

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

2 FDA Enforcement Statistics Summary Fiscal Year 2015

Like this post? Follow CluePoints on Twitter to stay up to date!

Risk-Based Monitoring Software

Webinar: Risk-Based Monitoring Implementation – What does ICH E6 Rev2 Mean for My Company?

By | Blog, Events, News | 2 Comments

With the official publication of the long awaited revision of the ICH E6 Guidelines, now is the time to take advantage of the new information to ensure appropriate consideration of risk in study design and management.

For this webinar, CluePoints is again teaming up with Paragon Solutions, to highlight the key changes in the mandate and explain how best to address these elements for successful Risk-Based Monitoring Implementation.

Expect to Learn:

  • Understanding the key ICH E6 updates related to Risk-Based Monitoring/Data Quality Oversight and their purpose
  • Understanding how Central Statistical Monitoring(CSM) and Key Risk Indicators(KRIs) will work for you
  • Critical-to-success methods for Central Statistical Monitoring and KRIs
  • Change Management – Using E6 R2 to support your organization’s transition to RBM
  • The Monitoring plan – not just for monitoring intervals anymore

When:

Tuesday, March 14th, 2017, 3:00pm GMT/ 11:00am EDT/ 08:00am PDT (Timing reflects  daylight savings time)

CluePoints – Finalists in The Clinical Informatics News 2017 Best Practices Awards at SCOPE, Jan 24th – 26th in Miami

By | Blog, News | No Comments

We’re thrilled to announce that CluePoints has been named as finalists for the Clinical Informatics News 2017 Best Practices Awards, for our award-winning Risk-Based Monitoring and Data Quality Oversight Solutions. The Clinical Informatics News Best Practices Awards recognize outstanding examples of applied strategic innovation – partnerships, deployments, and collaborations that manifestly improve the clinical trial process.

The winners will be announced at the SCOPE Summit for Clinical Ops Executives in Miami, Florida on January 25, 2017 – wish us luck!

The nomination for this award follows news that CluePoints signed a Cooperative Research and Development Agreement (CRADA) with the FDA. This Cooperative Research and Development Agreement (CRADA) explores a data driven approach to selecting sites which exhibit anomalies indicative of fraud, misconduct or sloppiness.

Also, be sure to stop by our booth (#509) at SCOPE to learn more about Risk-Based Monitoring, Data Quality Oversight and how our agreement with the FDA is driving how the regulator is interrogating submission data to select sites for inspection.

See you there!

CluePoints CEO, Francois Torche, to Present at SCOPE Summit for Clinical Ops Executives

By | Blog, News | No Comments

The 8th Annual SCOPE Summit for Clinical Ops Executives, taking place on January 24-26, 2017 in Miami, FL, will offer three stimulating days of in-depth discussions in 13 different conferences, six pre-conference workshops, and two symposia focused on issues related to each aspect of clinical trial planning and management.

Francois Torche, CEO, CluePoints will lead a session entitled “RBM Demystified: What We’ve Learned from the Practical Implementation of RBM and what the Regulators Want.” The session will take place on Wednesday, January 25th at 11:40 am.

Key objectives for Francois’ session include:

  • Best practice for Risk-Based Monitoring study planning process
  • Key pitfalls to avoid
  • How to differentiate between risk assessment, Key Risk Indicators (KRIs), and Data Quality Oversight Methods
  • How other Sponsors and CROs are leveraging a Risk-Based approach to monitoring and satisfying regulatory requirements

If you haven’t signed up for SCOPE Summit for Clinical Ops Executives, you can save $200 on registration using the following discount code: CLUE

Also, be sure to stop by our booth (#509) to explore the data-driven approach to quality oversight and learn more about how our recent agreement with the FDA is driving how the regulator is interrogating submission data to select sites for inspection

See you there!