remote monitoring

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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Temperature excursions and APIs to reduce study monitor work

I did a lot of local excursions the past 3 days – Jerusalem, Tel Aviv, Herzliya and Haifa.   For some reason, the conversations with 2 prospects had to do with refrigerators.   I do not know if this is Freudian or not, considering the hot weather of July in Israel. The conversations about refrigerators had to …

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Living in an ideal world where the study nurse isn’t overwhelmed by IT

Tigran examines the idea of using EDC edit checks to assure patient compliance to the protocol. How should I assure patient compliance to the protocol in a medical device trial? I get asked sometimes whether automated patient compliance deviation detection and response  is not overkill. After all, all EDC systems allow comparing input to preset ranges …

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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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What real-time data and Risk-based monitoring mean for your CRO

A widely neglected factor in cost-effective risk-based clinical trial monitoring is availability and accessibility of data. RBM methods used by a central clinical trial  monitoring operation that receives stale data (any data from patients that is more than a day old is stale) are ineffective. Every day that goes by without having updated data from …

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patient compliance in medical clinical device trials

Why medical device studies need business controls

There are some interesting analogies between cyber security and medical device clinical trials from a risk management perspective. Both areas are complex, vulnerable to human exploits and may result in loss of data. Medical device trials are not exempt from unexpected human behavior. Despite this concern, I find it significant that guidance for remote-risk-based monitoring …

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