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 […]
The gap between the proletariat and Medidata (or should I say Dassault)
We need a better UX before [TLA] integration The sheer number and variety of eClinical software companies and buzzwords confuses me. There is EDC, CTMS, IWRS, IVRS, IWRS, IRT, eSource, eCOA, ePRO and a bunch of more TLAs. For the life of me I do not understand the difference between eCOA and ePRO and why […]
4 strategies to get connected medical devices faster to FDA submission
Introduction Better designs, site-less trials, all-digital data collection and PCM (patient compliance monitoring) can all save time and money in connected medical device clinical trials. This article will help you choose which strategies will be a good fit to help you validate your connected medical device and its intended use for submission to FDA. What […]
Putting lipstick on the pig of electronic CRF?
Good online systems do not use paper paradigms. In this post – I will try and entertain you with historical perspective and quantitative tools for choosing an EDC system for your medical device study. Decades of common wisdom in clinical trials still hold to a paper-based data processing model. One of the popular EDC systems […]
Israel Biomed 2019-the high-social, low stress STEM conference
Impressions from Biomed 2019 in Tel Aviv This week was the annual 3 day Biomed/MIXiii (I have no idea what MIXiii means btw) conference in Tel Aviv. The organizers also billed it as the “18th National Life Science and Technology Week” (which I also do not know what that means). This was a particular difficult […]
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 […]
Invisible gorillas and detection of adverse events in medical device trials
What is easier to detect in your study – Slow-moving or fast moving deviations? This post considers human frailty and strengths. We recently performed a retrospective study of the efficacy of Flaskdata.io automated study monitoring in orthopedic trials. An important consideration was the ability to monitor patients who had received an implant and were on […]
Millennials are the future of clinical trial data management
Millennials, born between 1980 and 2000 and the first native generation of the digital age, are the quickly approaching additions to the modern workforce. Regardless of whether private or public sector Millennials are soon to become the bulk of the global workforce. At present, Millennials represent 34% of the current US workforce (up 9% from […]
