Patient compliance

Invisible gorillas and detection of adverse events in medical device trials

What is easier to detect in your study – Slow-moving or fast moving deviations? This post considers human frailty and strengths. We recently performed a retrospective study of the efficacy of  Flaskdata.io automated study monitoring in orthopedic trials. An important consideration was the ability to monitor patients who had received an implant and were on …

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Strong patient adherence in real life starts with strong people management

Patient adherence in real-life starts in clinical trials determining the safety, side effects and efficacy of the intervention, whether a drug or a medical device. Like any other industry – success in clinical trials is all about the people. The hugely successful movie – “Hidden figures” tells the story of the gifted black women mathematicians …

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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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The 3 tenets for designing a clinical data management system

Abstract: This post reviews the importance of 1) proper study design, 2) good data modeling and 3) realistic estimation of project timetables. The article concludes with a discussion of eSource and attempts to dispel some of the myths including how DIY EDC study build save time (they don’t). Enjoy! The trend of DIY: good for …

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Medical device clinical trials – not for the faint of heart

Patients in medical device clinical trials are on their phones.  On their phones for WhatsApp and for monitoring chronic conditions and reporting outcomes at home, at work and in the middle of a call to their friends. Medtech developers are looking to make their product development process as effective as  possible and are facing conflicting requirements when it …

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medical device clinical trials

A powerful alternative to checklists for assuring patient compliance

Danny Lieberman, founder and CEO of FlaskData.io the leading cloud provider of clinical compliance as a service, talks about breaking out of a patient compliance checklist mentality by starting with one question. The 3 pillars of GCP (good clinical practice) 1. Patient safety 2. Protocol compliance 3. Data quality (We note that setting the focus …

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