Patient compliance in clinical trials – the elephant in the room

Clinical trials cost a fortune. When a patient is non-compliant during the run-in/washout period, he/she is dropped out of the study. This costs the sponsor 5X: site costs for 2 patients, recruitment costs for 2 patients and loss of time. In other words, retention is more important than recruitment. This raises the question: why is […]

How understanding culture reduces risk in your clinical trials

It’s during the war the Russians are waging on Ukraine and I got on a thread on a blog about why Putin is so violent. I replied that from Putin’s perspective – the US and Europeans represented an existential threat to him when they pull Ukraine into NATO and when the US pushes democracy eastwards. […]

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 […]

I love being a CRA, but the role as it exists today is obsolete.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

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 […]

10 ways to detect people who are a threat to your clinical trial 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. […]

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 […]

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 […]

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 […]

The golden rule for digital therapeutics and connected medical devices

He who has the gold rules.   That’s all you need to know when it comes to privacy compliance. In the past 5 years, a lot has happened in the digital health space. Venture funding in 2018 was close to $10BN and a lot of work is being done in the area of digital therapeutics and […]