Assuring protocol compliance without checklists
At a site monitoring visit, the CRA works on assuring protocol compliance. Assuring protocol compliance is one of the 3 pillars of GCP: The 3 pillars of GCP (good clinical practice) 1. Patient safety 2. Protocol compliance 3. Data quality (We note that setting the focus on the primary clinical and safety end-points results in […]
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 […]
What takes precedence? GCP or hospital network security?
This is a piece I wrote a while back on my medical device security blog – Cybersecurity for medical devices. One of the biggest challenge of using connected medical devices in clinical trials is near real-world usage of devices that are not commercially-ready. We have a couple of customers that are performing clinical trials of […]
How to measure clinical response in medical device clinical trials
It is 19:15 and daylight savings time. It is too hot to go out and run or bike. Time to write. Today we were helping a customer with hardware issues. At the end of a long day, I started thinking that even hardware issues are valuable data to the decision-making process of measuring efficacy of […]
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 […]
Treating EDC Induced Dissociative Panic Disorder
There is considerable online discussion about real-world data in clinical trials, virtual trials, digital trials, medical IoT, wearables, AI, machine learning for finding best candidates for treatment and digital therapeutics. From the EDC vendors’ web sites – everything is perfect in a perfect world. Medidata Rave – for example: Run Your Entire Study On A Unified, […]
The golden rule for digital therapeutics and connected medical devices
He who has the gold rules. That’s all you need to know when it comes to privacy compliance. In the past 5 years, a lot has happened in the digital health space. Venture funding in 2018 was close to $10BN and a lot of work is being done in the area of digital therapeutics 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 […]
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 […]
Strong patient adherence in real life starts with strong people management
Patient adherence in real-life starts in clinical trials determining the safety, side effects and efficacy of the intervention, whether a drug or a medical device. Like any other industry – success in clinical trials is all about the people. The hugely successful movie – “Hidden figures” tells the story of the gifted black women mathematicians […]
