Clinical trial manager

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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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 …

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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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Israel Biomed 2019-the high-social, low stress STEM conference

Impressions from Biomed 2019 in Tel Aviv This week was the annual 3 day Biomed/MIXiii (I have no idea what MIXiii means btw) conference in Tel Aviv.  The organizers also billed it as the “18th National Life Science and Technology Week” (which I also do not know what that means). This was a particular difficult …

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The best alternative to paper in medical device clinical trials

There is an urban legend that paper is cheaper than EDC $1000/subject for paper-based data management (the going rate in Israel)  is a lucrative business for small CROs, independent data managers and biostatisticians, but $1000/subject is not the same as “total cost of ownership” or TCO. The TCO of doing a clinical trial for an …

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The key is not first to eSource, the key is smart to market

This post is not for the Pfizers, Novartis, Merck and GSK giants of the life science industry. Its for the innovators, the smaller, creative life science companies that are challenged by the costs, the regulatory load and complexity of executing a clinical trial. This post is dedicated to the startup entrepreneurs of the world. Building an EDC …

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Automated detection and response – a pattern of low-concern and high-impact

It is the hottest July in Israel in 17 years and the day after Tisha B’Av – a day of mourning and fasting where the Jews remember the destruction of the Temple and attempt to be nice to each other for a few days. A time for reflection. Today I want to talk about an …

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medical device clinical trials - remote monitoring

Why the CRO model for drug and device trials is broken and how to fix it

Who said: ‘If you are not part of the solution, you must be part of the problem’? This appears to be a misquotation of Eldridge Cleaver  author of the 1968 book “Soul on Ice” and early leader of the Black Panthers. The correct (full) quote is: ‘There is no more neutrality in the world. You either …

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