A word to Teva on firing employees and assuring data security
To be able to do something before it exists, sense before it becomes active, and see before it sprouts. The Book of Balance and Harmony (Chung-ho chi). A medieval Taoist book In early December 2017, the Israeli pharmaceutical generics company Teva announced it would lay off about 1,700 of its employees in Israel, who make up […]
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 […]
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 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 – […]
An attack modeling approach to medical device clinical trials
What does taking off your shoes and belt in the airport have in common with risk assessment in clinical trials? Today we talk about the drawbacks of traditional risk assessment and propose an alternative approach to clinical trial risk assessment that is based on data and considering plausible attacks on your trial as opposed to fixed protocols and […]
Why paper should be your first choice for a medical device clinical trial
6 reasons to use paper in your clinical trial You’ve been considering cloud EDC for your next clinical trial, but you are put off by the perceived challenges and costs of implementation and operation. You shudder at the thought of DIY EDC solutions like Clincapture or Medrio and don’t have the budget for Medidata. For many […]
5 ways to reduce costs and accelerate medical device clinical trials
Time is money The economic model of a multi-center clinical trial is based on a commercial biotech/biomed/pharma company sponsoring and funding clinical research in order to prove efficacy and or safety of a new drug or medical device. In fact, although the sponsor has the most at stake by far, in clinical trials, sponsors and […]
