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patient compliance in medical clinical device trials

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 …

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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 …

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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 …

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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 …

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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 …

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clinical trial monitoring

5 key questions for choosing clinical data management software

Pricing from the big EDC vendors is complex and confusing and the overlap between CRO clinical data management services and their EDC solutions locks you into a proprietary system of high-costs and expensive professional services. The non-transparency of the clinical data management market As the CEO of an innovative biomed or biotech company doing clinical trials, …

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