Implementing an EDC to take advantage of risk-based monitoring
Clinical trial monitoring is 30-40% of your project costs. At least half of that cost is manual work and SDV activities which can be eliminated with use of modern technologies like electronic source documents and remote risk-based monitoring. In this post, we take a look at how you can automate routine data management activities […]
Integrating mHealth in medical device clinical trials
Introduction mHealth evolved largely an application for developing countries, due to the rapid growth of mobile phone penetration in low-income nations. But mHealth is now a game-changer for clinical trials, enabling electronic patient reported outcomes and integration with medical devices using standard hardware and mobile operating systems. There are 3 key use cases of mHealth […]
The great ripoff of SDV in medical device studies
Question Are you still doing 100% SDV in your medical device clinical trial? Here are some facts from medical device clinical trials: 30% of your study budget is for monitoring and 50% of monitoring is for SDV For a $1M study – you are spending $150k for SDV. What do you get for your $150K? […]
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 healthcare IoT devices need data monitoring
Use of healthcare IoT devices for sensing patient vital signs enables fast and cost-effective remote monitoring of patient safety and data quality – however the challenges start after collecting the data. Healthcare IoT for sensing patient state is not a panacea. Monitoring of data you collect in your clinical trial using healthcare IoT requires up-front […]
Using AI to assure patient compliance in heart failure patients
Can AI be used to help patients with heart failure? Each year cardiovascular disease (CVD) causes 3.9 million deaths in Europe and over 1.8 million deaths in the European Union (EU). CVD accounts for 45% of all deaths in Europe and 37% of all deaths in the EU. In 2015, almost 49 million people were […]
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 […]
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 […]
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 – […]
