High-performance clinical teams speak softly

The advantages of speaking softly I started thinking about the constraints on eClinical technology for decentralized clinical trials and patient-centric product development. The best planned patient-centric trial will not succeed if the data quality is poor at the sites. When a CRA on the team is disgruntled, it is infectious. Speed and efficiency in your …

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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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How to ensure patient adherence in decentralized clinical trials

With COVID-19, it is challenging to physically visit patients in clinical trials. Life science companies are increasingly  turning to decentralized clinical trial models. With 10X more data from patients and their connected devices, how can we assure patient adherence to the clinical protocol Are we discovering new opportunities or forgetting old lessons learned? In this …

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How to get digital health apps to work together – the power of simplicity

Sunrise off the coast of the Dead Sea in Israel We are using too many buzzwords to defeat SARS-COV-2 I thought about buzz-words last night. My wife is now a compulsive news watcher. Personally — TV news and papers bother me from getting productive work done at our clinical data startup flaskdata.io — accelerating clinical trials for …

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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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How to swim in the cold water of decentralized clinical trials

(The water in the pool in Cascais in October was < 12 degrees) There are over 135 COVID-19 vaccine candidates in the pipeline at the time of writing this post – June 20, 2020. Although there are always personal, political and emotional preferences, we should probably not select a clinical data management platform like we …

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Hack back the user interface for clinical trials

As part of my campaign for site-coordinator and study-monitor centric clinical trials; we first need to understand how to exploit a vulnerability in human psychology. As a security analyst, this is the way I look at things – exploits of vulnerabilities. In 2007, B.J. Fogg, founder and director of the Stanford Behavior Design Lab taught a …

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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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