Preventing drug counterfeiting
Counterfeiting is old as money itself. Drug counterfeiting is no exception. In this post, we’ll share an analytical approach that you can use to estimate the risk of drug counterfeiting to your drug products. Why are Medicines a Target for counterfeiting? Pharma is a highly regulated sector. Why do drugs attract counterfeiters? Fakes can be […]
What risks really count for your clinical trials?
Is there a “black-box” risk management solution for your clinical trial? What clinical trial risks are the most important for you and your company? Risk mitigation and risk management for your clinical trials What clinical trial risks really count for your company? No question is more important for implementing an effective program of risk-mitigation and […]
How to ensure patient adherence in decentralized clinical trials
Patient adherence in clinical trials without technology How can you assure patient adherence to the protocol, when you don’t see the patient? Life science companies are increasingly turning to decentralized clinical trial models. This means that patients are home alone. They use ePRO to record side effects and outcomes from the treatment. With 10X more […]
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. […]
I love being a CRA, but the role as it exists today is obsolete.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
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. […]
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 […]
