People, not digital for supporting patients in medical device clinical trials
1 in 7 American adults live alone Medical device clinical trials are performed under conditions that are near to real-life use by the patient. That means that a medical device for monitoring cardiovascular (CV) risk, CHF (congestive heart failure) and other cardiac disorders is used by a subject in medical device clinical trial at home […]
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 […]
The 2 most common mistakes in Clinical Research Data Management
Another survey piece that David wrote about common mistakes in clinical data management and some basic controls to stay from the common issues. Use automated monitoring to empower people We are all human. As much as we would like to rely on technology to automate every sector of clinical trial research, we still need the […]
The best alternative to paper in medical device clinical trials
There is an urban legend that paper is cheaper than EDC $1000/subject for paper-based data management (the going rate in Israel) is a lucrative business for small CROs, independent data managers and biostatisticians, but $1000/subject is not the same as “total cost of ownership” or TCO. The TCO of doing a clinical trial for an […]
Why medical IoT is outside your comfort zone
Connected medical devices or (medical IoT – Internet of Things) outnumber people. This is an article David wrote about 1.5 years ago. It is a good general introduction for the layman to the challenges of developing connected medical devices in clinical trials but it is not a technical treatment and doesn’t get into the really […]
why a medical device is now the biggest risk in your clinical trial
Of all of the connections brought about by the Internet of Things, nothing is more frightening than the notion of an unsecured medical device. The magnitude of risk associated with medical devices and the Internet of Things is a gripping proposition with 67% of medical device makers expecting an attack on their devices while only […]
The pay-off for reducing cycle time in medical device clinical trials
Well – it certainly isn’t science and technology innovation or even the FDA.At a recent executive roundtable, according to Tufts University’s Center for the Study of Drug Development director and associate professor Ken Getz, it is that many pharma corporations and CROs have not yet fully embraced the newest, most efficient technologies, and this has been […]
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 […]
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 […]
Dates: the silent death in medical device clinical trials
Jenya Konikov-Rozenman Jenya is a co-founder and VP Clinical at Flaskdata.io. 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 FlaskData.io customer operations with super-human devotion to customer delivery. Jenya has 2 children – […]
