Risk management

How to ensure patient adherence in decentralized clinical trials

With COVID-19, it is challenging to physically visit patients in clinical trials. Life science companies are increasingly  turning to decentralized clinical trial models. With 10X more data from patients and their connected devices, how can we assure patient adherence to the clinical protocol Are we discovering new opportunities or forgetting old lessons learned? In this …

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I love being a CRA, but the role as it exists today is obsolete.

I think that COVID-19 will be the death knell for on-site monitoring visits and SDV.    Predictions for 2020 and the next generation of clinical research – mobile EDC for sites, patients and device integration that just works. I’m neither a clinical quality nor a management consultant. I cannot tell a CRO not to bill …

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Using automated detection and response technology mitigate the next Corona pandemic

What happens the day after?   What happens next winter? Sure – we must find effective treatment and vaccines.  Sure – we need  to reduce or eliminate the need for on-site monitoring visits to hospitals in clinical trials.  And sure – we need to enable patient monitoring at home. But let’s not be distracted from 3 …

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10 ways to detect people who are a threat to your clinical trial

Flaskdata.io helps Life Science CxO teams outcompete using continuous data feeds from patients, devices and investigators mixed with a slice of patient compliance automation. One of the great things about working with Israeli medical device vendors is the level of innovation, drive and abundance of smart people. It’s why we get up in the morning. …

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Develop project management competencies to speed up your clinical trials

The biggest barrier to shortening clinical trial data cycle times is not recruitment.   It is not having a fancy UI for self-service eCRF forms design.   It is not software. It is not, to paraphrase Medidata, having the ability to Run Your Entire Study On A Unified, Intelligent Platform Built On Life Science’s Largest Database. It …

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Why Microsoft is evil for medical devices

Another hot day in paradise. Sunny and 34C. Not a disaster but still a PITA We just spent 2 days bug-fixing and regression-testing code that was broken by Microsoft’s June security update to Windows operating systems and Explorer 11.    Most of the customers of the FlaskData EDC, ePRO, eSource and automated detection and response …

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patient compliance in medical clinical device trials

Killed by code in your connected medical device

Are we more concerned with politicians with pacemakers or families with large numbers of connected medical devices? Back in 2011, I thought it would only be a question of time before we have a drive by execution of a politician with an ICD (implanted cardiac device). May 2019, with mushrooming growth in connected medical devices (and …

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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 …

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Strong patient adherence in real life starts with strong people management

Patient adherence in real-life starts in clinical trials determining the safety, side effects and efficacy of the intervention, whether a drug or a medical device. Like any other industry – success in clinical trials is all about the people. The hugely successful movie – “Hidden figures” tells the story of the gifted black women mathematicians …

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