When is patient compliance important in medical device clinical trials?
In this post, Danny Lieberman, founder of flaskdata.io , discusses when patient compliance is crucial for your medical device clinical trial and when patient compliance is a negligible factor to success of the study. From adverse events to patient compliance My original goal for Flaskdata.io was to use machine learning to predict onset of adverse events […]
Israeli Medical device innovation for high patient compliance
One of the most challenging problems in medical device clinical trials and in real-life is how to achieve high levels of patient compliance to the protocol. Automated patient compliance technology in medical device clinical trials is confronting CROs with an unpleasant status-quo of SDV as a low-value-add, high-cost, time-consuming activity for patient compliance assurance. The approach […]
Invisible gorillas and detection of adverse events in medical device trials
What is easier to detect in your study – Slow-moving or fast moving deviations? This post considers human frailty and strengths. We recently performed a retrospective study of the efficacy of Flaskdata.io automated study monitoring in orthopedic trials. An important consideration was the ability to monitor patients who had received an implant and were on […]
Why paper is not an option for your medical device clinical trial
This is a piece David wrote a couple of years ago originally entitled “Why you cannot afford to use paper in your first Phase I efficacy trial for your medical device”. David’s premise is that people do not like change. We have heard the axiom change is good all throughout our lives, but the fact remains that […]
A structured 7 step process for risk assessment of a decentralized clinical trial
In this essay, I discuss a systematic methodology for evaluating risk in your decentralized clinical trial. This is a methodology that has proven itself in hundreds of security and privacy compliance risk assessment projects in a wide variety of healthcare, clinical and IT scenarios. It is a given that the people charged with your clinical […]
Why EDC is essential for any medical device clinical trial
This is a post David wrote a while back and it still seems relevant. If you would have asked me 2 years ago – I would have told you that in 2018, no one would be doing paper medical device clinical trials the same way that no one does paper accounting. I would have thought […]
What does risk-based monitoring mean for CROS?
Contract research organizations (CROs) should implement risk-based monitoring (RBM) as a top priority for medical device clinical studies. Use of modern data technologies for remote risk-based monitoring can help reduce non-value added rework, and dramatically improve patient compliance in medical device clinical trials and help speed up time to statistical report. The goal of a […]
How to sustain high patient compliance in medical device trials
A comparison between pharma trials and medical device clinical trials The differences between medical device trials and drug efficacy studies are similar to the differences between starting a law firm and starting a business training runners – while both are businesses in a basic sense, they each have specific criteria to adhere to regarding government […]
Is social networking a threat or an opportunity for patient compliance?
How social networking helps medical device clinical trials achieve high rates of recruitment and patient compliance.
The role of your biostatistician for success in medical device clinical trials
The importance of biostatistics in medical device clinical trials In order to understand the importance of biostatistics in medical device clinical trials we talked to Dr. Lisa Deutsch. Lisa Deutsch, Ph.D is a Managing Partner at BioStats Statistical Consulting Ltd. Lisa is one of the rare breed of biostatisticians that are specialized practitioners in biostatistics […]
