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Why Remote Clinical Trial Monitoring is the New Standard The COVID-19 pandemic has accelerated the ongoing shift to remote clinical trial monitoring. Remote site access and monitoring platforms are now an essential element of the clinical trial process and a vital connection between the sponsor, clinical research organization (CRO), and the research site. [...]
Innovation matters in Clinical Research… The adoption of new technology, in any industry, follows a familiar cycle outlined by Geoffrey Moore in his book Crossing the Chasm, Innovators: Innovators are the first individuals to adopt an innovation. These individuals/teams are willing to take a risk to help advance a solution. Early Adopters: These are the [...]
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 [...]
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 [...]
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 [...]
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 [...]
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 [...]
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 [...]
