compliance automation

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 …

Develop project management competencies to speed up your clinical trials Read More »

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 …

Why Microsoft is evil for medical devices Read More »

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 …

The gap between the proletariat and Medidata (or should I say Dassault) Read More »

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 …

4 strategies to get connected medical devices faster to FDA submission Read More »

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 …

Invisible gorillas and detection of adverse events in medical device trials Read More »

Scroll to Top