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 […]

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 […]

Living off generic solutions developed in the past

I recently read some posts on Fred Wilson’s blog and it was impressive that he writes every day. I’ve fallen into the trap of collecting raw material and then waiting to find time to write a 2000-word essay on some topic of importance to me.   But, I think it was Steve Jobs who said the […]

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 automated study monitoring in orthopedic trials. An important consideration was the ability to monitor patients who had received an implant and were on […]

Why EDC is essential for any medical device clinical trial

This is a post David wrote a while back and it still seems relevant.  If you would have asked me 2 years ago – I would have told you that in 2018, no one would be doing paper medical device clinical trials the same way that no one does paper accounting.   I would have thought […]

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 […]

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 […]

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 […]

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 […]

A powerful alternative to checklists for assuring patient compliance

Danny Lieberman, founder and CEO of 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 […]