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 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. […]
Competitive buzzwords in EDC companies
We recently did a presentation to a person at one of the big 4 pharma. His job title was Senior IT Project Manager Specialized in Health IT. I looked at the persons LinkedIn profile before the call and I noticed that the sentence is in past tense. Specialized in Health IT implying that he was […]
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 […]
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 […]
Bionic M2M: Are Skin-mounted M2M devices – the future of clinical trials?
There is a lot of hype about wearables. One of the best ways to correlate patient compliance with patient biometrics is for the patient to wear the sensor on her skin. I started thinking about skin-mounted devices again after reading the press release about the BioSerenity Series B, so I dug up an essay I wrote […]
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 […]
Perverse incentives
The perverse incentive for the high costs of medical devices and delay to market The CRO outsourcing model and high US hospital prices result in higher total CRO profits via higher costs to companies developing innovative medical devices. These costs are passed down to consumers after FDA clearance. We’ll take a look at the cost […]
Patient compliance – the billion dollar question
The high failure rate of drug trials The high failure rate of drugs in clinical trials, especially in the later stages of development, is a significant contributor to the costs and time associated with bringing new molecular entities to market. These costs, estimated to be in excess of $1.5 billion when capitalized over the ten […]
