Risk Based Monitoring

/Risk Based Monitoring
22 08, 2019

The Evolution of Clinical Trial Monitoring through the eISF

2019-08-22T14:49:40-04:00

Clinical Trial Monitoring is an essential element of the clinical trial process and a vital connection between the Sponsor/CRO and the Research Site. Monitoring is the Sponsor/CRO’s obligation to ensure that the Research Site conducts the trial per the protocol, SOPs, GCP, and any other regulatory requirements. Ultimately, when conducting an IND trial, regulations [...]

The Evolution of Clinical Trial Monitoring through the eISF2019-08-22T14:49:40-04:00
27 03, 2018

The Impact of Remote Monitoring on CRAs | Central Monitoring Summit

2019-08-02T16:02:50-04:00

While presenting at Central Monitoring Summit 2018, Elizabeth Robinson of Horizon Pharma shared a strong data point: In the coming years, Clinical Research Associates (CRAs) will experience more change to their jobs than any other research profession (2017 Applied Clinical Trials survey). This statement spurred a conversation amongst the room about what will change [...]

The Impact of Remote Monitoring on CRAs | Central Monitoring Summit2019-08-02T16:02:50-04:00
7 02, 2018

Innovations | The time is now for eRegulatory and eSource

2019-08-02T16:05:10-04:00

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 [...]

Innovations | The time is now for eRegulatory and eSource2019-08-02T16:05:10-04:00
27 04, 2017

eClinical tools to dClinical tools

2019-08-02T16:08:35-04:00

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 [...]

eClinical tools to dClinical tools2019-08-02T16:08:35-04:00
6 10, 2016

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

2019-08-01T15:08:21-04:00

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 [...]

4 Takeaways from the 4th Annual Embracing Change Conference for Clinical Research2019-08-01T15:08:21-04:00
9 08, 2015

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

2019-08-01T14:46:44-04:00

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 [...]

Making Risk Based Monitoring Real for the Other 50% of Sponsors2019-08-01T14:46:44-04:00
3 08, 2015

Opposing Views on FDA Complete Response Letters

2019-08-01T14:38:39-04:00

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 [...]

Opposing Views on FDA Complete Response Letters2019-08-01T14:38:39-04:00
1 02, 2015

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

2019-08-01T14:34:11-04:00

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 [...]

Clinical Trial Data Sharing: Has the IOM Taken on Too Big a Challenge?2019-08-01T14:34:11-04:00
16 12, 2014

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

2019-08-01T13:57:43-04:00

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 [...]

What’s really happening with Risk Based Monitoring and trial sites?2019-08-01T13:57:43-04:00