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 […]
The LA Freeway model of clinical monitoring
A freeway paradigm helps explain why onsite visits by study monitors don’t work and helps us plan and implement an effective system for protocol compliance monitoring of all sites, all data, all the time that saves time and money. But first – let’s consider some special aspects of clinical trial data: Clinical trial data is highly dimensional data. Clinical […]
5 ways to make your clinical trials run real fast
This week, we had a few charming examples of risk management in clinical trials with several of our customers. I started thinking about what we could do to get things to run real fast and avoid some of the inevitable potholes and black swans that crop up in clinical trials. Engaged in basic science and […]
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 […]
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 […]
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 […]
Living off generic solutions developed in the past
I recently read some posts on Fred Wilson’s blog and it was impressive that he writes every day. I’ve fallen into the trap of collecting raw material and then waiting to find time to write a 2000-word essay on some topic of importance to me. But, I think it was Steve Jobs who said the […]
What real-time data and Risk-based monitoring mean for your CRO
A widely neglected factor in cost-effective risk-based clinical trial monitoring is availability and accessibility of data. RBM methods used by a central clinical trial monitoring operation that receives stale data (any data from patients that is more than a day old is stale) are ineffective. Every day that goes by without having updated data from […]
How to secure your data in mobile medical device clinical trials
So you are getting ready to run medical device clinical trials with your mobile medical app or a medical appliance that is connected to the Internet via Wifi in the patient’s home network. How do you secure your device and your cloud systems and how do you comply with the HIPAA Security Rule that is a […]
Why medical device studies need business controls
There are some interesting analogies between cyber security and medical device clinical trials from a risk management perspective. Both areas are complex, vulnerable to human exploits and may result in loss of data. Medical device trials are not exempt from unexpected human behavior. Despite this concern, I find it significant that guidance for remote-risk-based monitoring […]
