Risk Based Monitoring

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27 04, 2017

eClinical tools to dClinical tools

2017-07-14T15:44:35+00:00

Gartner’s Michael Shanler was one of the first to recognize the trend of dClinical. He noticed that a new generation of software vendors was emerging who handled project management and reporting in a new way. Florence agrees with Michael’s observation, which is why we’re building tools that align with a dClinical approach. An abbreviated history [...]

6 10, 2016

4 Takeaways from the 4th Annual Embracing Change Conference for Clinical Research

2017-06-11T17:36:51+00:00

The 4th Annual Embracing Change Conference for Clinical Research was a well-produced event from Arizona State University’s Clinical Research Management program. If you did not make it and would like a copy of the Status of Paperless Trials Presentation, send Florence a short email by clicking here.   A substantial portion of the conference revolved [...]

9 08, 2015

Making Risk Based Monitoring Real for the Other 50% of Sponsors

2017-06-11T17:36:53+00:00

This year we’ve met with 45 pharmaceutical, biotech, and device sponsors about both risk-based and remote-based monitoring (the combination referred to as RBM), and we’re seeing sponsors migrate to RBM in very different ways. We encountered three main RBM positions: Source: Florence HC industry interviews, 2015 Targeted. 50% have moved to targeted monitoring based on [...]

3 08, 2015

Opposing Views on FDA Complete Response Letters

2016-05-09T17:24:12+00:00

Recently, the British Medical Journal published an analysis on how pharmaceutical companies publicly address Complete Response Letters (CRL) from the FDA, more specifically from the Center for Drug Evaluation and Research (CDER). While the EMA publishes data from refusal assessment reports, the FDA does not fully disclose information with CRLs because of privacy rules around unapproved applications. [...]

1 02, 2015

Clinical Trial Data Sharing: Has the IOM Taken on Too Big a Challenge?

2017-06-11T17:36:53+00:00

In January of 2015, the Institute of Medicine (IOM) made an historic call to increase the sharing of data gathered in clinical trials. The aim to increase knowledge and subsequently increase the rate of therapy development is clear. How does this work? Collectively, sharing trial data would reduce cost and data leakage by eliminating duplicate efforts for sponsors. [...]

16 12, 2014

What’s really happening with Risk Based Monitoring and trial sites?

2017-06-11T17:36:54+00:00

Is Risk Based Monitoring a help? Depends on where you sit in the clinical trial process. For example, in a recent Wall Street report, a CRO boasts: “20,000 sites and 250,000 patients now remotely monitored using award winning technology.” Meanwhile, the Florence Healthcare team met with dozens of sites around the world this quarter, and here’s [...]