EDC

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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A better tomorrow for clinical trials

A better tomorrow – Times of crisis usher in new mindsets By David Laxer. Spoken from the heart. In these trying days, as we adjust to new routines and discover new things about ourselves daily, we are also reminded that the human spirit is stronger than any pandemic and we have survived worse. And because we …

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Streaming clinical trials in a post-Corona future

Last week, I wrote about using automated detection and response technology to mitigate the next Corona pandemic. Today – we’ll take a closer look at how streaming data fits into virtual clinical trials. Streaming – not just for Netflix Streaming real-time data and automated digital monitoring is not a foreign idea to people quarantined at …

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So what’s wrong with 1990s EDC systems?

Make no doubt about it, the EDC systems of 2020 are using a 1990’s design. (OK – granted, there are some innovators out there like ClinPal with their patient-centric trial approach but the vast majority of today’s EDC systems, from Omnicomm to Oracle to Medidata to Medrio are using a 1990’s design. Even the West …

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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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Good strategy bad strategy for study monitors in connected device studies

Friday is an off-day in Israel and I try to work on projects or read. I am now reading Richard Rumelt’s book Good strategy Bad strategy: The difference and why it matters.  The core content of a strategy is a diagnosis of the situation at hand, creation or identification of a guiding policy for dealing …

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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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