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 […]
5 critical factors in choosing software for clinical data management
Here are some practical guidelines to selecting an EDC system. Some basic blocking and tackling. Always good. EDC not paper Electronic data capture (EDC) systems are basically the standard for clinical trial data management. To put it simply, the old-school process of using a paper case report form (CRF) and then uploading it into an […]
3 practical tips for cost-effective clinical monitoring
Originally posted by Jenya Konikov-Rozenman on May 31, 2016 in Clinical Trial Monitoring Can you use technology to reduce the costs of your clinical trial and shorten your time from study data lock to regulatory submission? Jenya talks about how medtech developers can save money and reduce their time to market. If you are a medtech company […]
Connecting with serious ill children at the Jordan River Village
Working in a startup like FlaskData.io developing cloud-based clinical data management software is like a triathlon ( I did the Eilat triathlon in 2013 so I can compare). There is a long swim of developing software where you are on your own (and maybe get kicked in the head) and then the adrenaline rush of launch when […]
2 mistakes you do not want to make in your medical device clinical trial
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 – […]
Serious fun at the Jordan River Village
Working in a startup like FlaskData.io is a combination of riding a roller-coaster and doing a 100K bike ride. There are downs (losing deals) and ups (winning deals), and adrenaline rushes(releasing great software) plus you need the stamina to ride strong on the hills and fast after the crest. I am a serious amateur musician and everyday bike rider so I […]
Invisible gorillas and clinical trial monitoring
Danny Lieberman Invisible gorillas and detection of severe adverse events. This weekly episode considers human frailty and strengths. We recently performed a retrospective study of the efficacy of the FlaskData.io tools for remote study monitoring in orthopedic trials. An important consideration was the ability to monitor patients who had received an implant and were on a […]
Airport security versus clinical trial monitoring
Airport security versus clinical trial risk management What does taking off your shoes and belt in the airport have in common with risk assessment in COVID-19 clinical trials? Today we talk about the drawbacks of traditional clinical trials risk assessment for COVID-19. The notion of fixed risks determined at the beginning of the project is […]
Why the CRO model for drug and device trials is broken and how to fix it
Who said: ‘If you are not part of the solution, you must be part of the problem’? This appears to be a misquotation of Eldridge Cleaver author of the 1968 book “Soul on Ice” and early leader of the Black Panthers. The correct (full) quote is: ‘There is no more neutrality in the world. You either […]
5 things that make mHealth apps successful
In case you were thinking about scanning this post before scooting over to sign up to get 30 days free on our new managed Cloud clinical data collection and monitoring service – I will give you the bottom line before we start. Less technology and less information and more people. Patient monitoring is successful when it […]
