Develop project management competencies to speed up your clinical trials
The biggest barrier to shortening clinical trial data cycle times is not recruitment. It is not having a fancy UI for self-service eCRF forms design. It is not software. It is not, to paraphrase Medidata, having the ability to Run Your Entire Study On A Unified, Intelligent Platform Built On Life Science’s Largest Database. It […]
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 […]
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 […]
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 […]
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 […]
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 […]
Why EDC is essential for any medical device clinical trial
This is a post David wrote a while back and it still seems relevant. If you would have asked me 2 years ago – I would have told you that in 2018, no one would be doing paper medical device clinical trials the same way that no one does paper accounting. I would have thought […]
Is social networking a threat or an opportunity for patient compliance?
How social networking helps medical device clinical trials achieve high rates of recruitment and patient compliance.
