medical device clinical trials

10 free ways to reduce risk in your medical device clinical trial

You cannot outsource quality in your medical device clinical trial Collecting low-quality data means that your trial is likely to fail. You will not be able to prove or disprove the scientific hypothesis of your medical device clinical trial. You will have wasted your time. You cannot outsource quality, you have to build it into …

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The LA Freeway model of clinical monitoring

A freeway paradigm helps explain why onsite visits by study monitors don’t work and helps us plan and implement an effective system for protocol compliance monitoring of all sites, all data, all the time that saves time and money. But first – let’s consider some  special aspects of clinical trial data: Clinical trial data is highly dimensional data. Clinical …

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10 ways to detect people who are a threat to your clinical trial

Flaskdata.io helps Life Science CxO teams outcompete using continuous data feeds from patients, devices and investigators mixed with a slice of patient compliance automation. One of the great things about working with Israeli medical device vendors is the level of innovation, drive and abundance of smart people. It’s why we get up in the morning. …

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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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How to improve patient compliance in your medical device study

Here’s an idea that will make you slap your forehead. You can just stop transcribing case reports on paper. FDA eSource guidance recommends direct data entry into your EDC.  The eCRF becomes electronic source and you eliminate source document verification. You save money, systems, time and you get to go home early. Don’t let people confuse …

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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, …

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patient compliance in medical clinical device trials

Killed by code in your connected medical device

Are we more concerned with politicians with pacemakers or families with large numbers of connected medical devices? Back in 2011, I thought it would only be a question of time before we have a drive by execution of a politician with an ICD (implanted cardiac device). May 2019, with mushrooming growth in connected medical devices (and …

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