Patient compliance – the billion dollar question

The high failure rate of drug trials The high failure rate of drugs in clinical trials, especially in the later stages of development, is a significant contributor to the costs and time associated with bringing new molecular entities to market. These costs, estimated to be in excess of $1.5 billion when capitalized over the ten […]

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 […]

Important EDC features for medical device clinical trials

Medidata Rave and its CTMS companion product iMedidata are a far more comprehensive solution than OpenClinica but when you choose EDC software for medical device clinical trials, you enter a realm of unique requirements involving connectivity, security, privacy, API integration and specific interfaces to hardware. Electronic data capture software (EDC software) systems have demonstrated that […]

Homeostasis and medical device clinical trials

Danny talks about how to strike a good balance between people and technology for monitoring medical device clinical trials. Are real-time alerts too much of a good thing for monitoring your study? Maybe real-time alerts for patient compliance in medtech studies is just a fad – a fad just like WhatsApp. I had a conversation […]

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 […]

How to overcome 5 eSource implementation challenges

Jenya wrote a piece about the challenges of clinical trials operations change management for regulatory people who have to work with medical technology developers and I just had to write my own intro. Frankly, its easier to talk about change for other people than for yourself. A lot easier.  I have written here, here and here […]

Cost effective EDC for medical device clinical trials

There is a saying in American English dating back to the 1940’s – “Call me when you have a nickel in your pocket”. With limited budgets, small, innovative medical device vendors will be looking at the nickel in their pocket and thinking that they cannot afford a cloud EDC offering for clinical data management and opt […]

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 […]

Assuring patient compliance to the study protocol-spending smart on monitoring

Today I want to go beyond having compelling ideas, a team and a great market opportunity and talk about what you need to successfully execute a clinical trial on your way to FDA approval. Sometimes there is nothing more powerful than the passion and vision of an entrepreneur. But passion and vision are just not […]

Dates: the silent death in medical device clinical trials

Jenya Konikov-Rozenman Jenya is a co-founder and VP Clinical at Jenya has a masters degree in biotechnology from the Hebrew University and is a doctoral candidate at Tel Aviv in medical science. She is GCP and CRA certified and leads customer operations with super-human devotion to customer delivery. Jenya has 2 children – […]