Data capture by sites is activity, not achievement

Never mistake data collection activity for an achievement Recruiting and caring for patients (whether at home or on site) is a research site responsibility. Capturing pages (note the paper paradigm!) is one of the key billable metrics for a site. While data collection, detection of exceptions and action to close issues are all activities essential […]

Living in an ideal world where the site coordinator is not overwhelmed by IT

Tigran examines the idea of using EDC edit checks to assure patient compliance to the protocol. How should I assure patient compliance to the protocol in my clinical trials? I get asked sometimes whether automated patient compliance deviation detection and response  is not overkill. After all, all EDC systems allow comparing input to preset ranges and […]

10 free ways to reduce risk in your medical device clinical trial

You cannot outsource quality in your medical device clinical trial Collecting low-quality data means that your trial is likely to fail. You will not be able to prove or disprove the scientific hypothesis of your medical device clinical trial. You will have wasted your time. You cannot outsource quality, you have to build it into […]

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 […]

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 […]

Temperature excursions and APIs to reduce study monitor work

I did a lot of local excursions the past 3 days – Jerusalem, Tel Aviv, Herzliya and Haifa.   For some reason, the conversations with 2 prospects had to do with refrigerators.   I do not know if this is Freudian or not, considering the hot weather of July in Israel. The conversations about refrigerators had to […]

Doctor-Patient Communication – the key to success and the struggle to succeed.

Katherine Murphy, Chief Executive of the Patients Association London once said, “The huge rise in complaints in relation to communication and a lack of respect are of particular concern. Patients are not receiving the compassion, dignity and respect which they deserve.” As clinical trial technology guys, you would assume that we love code more than […]

Urban medical legends

Because I was trained as a solid-state physicist I am skeptical of many medical claims – including the efficacy of digital health apps.  Gina Kolata wrote this post last week.  I’ll let you decide for yourself. You might assume that standard medical advice was supported by mounds of scientific research. But researchers recently discovered that […]

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 […]

Obsessed with patient compliance

Obsessed with patient compliance I’m watching a series of short videos done by Techstars founder Brad Feld. Brad talks about founders needing to be obsessive. I am totally obsessed with patient compliance. The key to speed in medical device trials is eliminating non-value-added activities and automating everything else. There are a lot of smart people working […]