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 […]
3 critical success factors for patient compliance automation
Even if you are new in pharmaceutical or medical device clinical trial industry, it is more probable than not that you recognise the value of accurate and secure data capture. After all, whether Phase I or Phase IV, the essential purpose of conducting clinical studies is to collect and manage quality data at the behest […]
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 […]
The 2 big data disconnects in clinical data management
Why data is important There are 2 reasons: Determining the results of your clinical trials depends on the data Governance of the clinical trial depends on the data – but not necessarily the same data. Data-driven management is an approach that values decisions based on verifiable empirical data. The data-driven approach is crucial to success of modern, […]
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 – […]
Forging partnerships for high patient compliance
Clarifying ownership of patient compliance in medical device clinical trials requires building risk management into the operation and forging a good partnership between clinical operations, biostatistics and the clinical data management provider who can provide the technical infrastructure for calculating compliance indicators from the EDC, ePRO and connected medical devices in the study. Although this […]
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 […]
ICH GCP and EU Regulations impact on clinical trial monitoring
October 2015: EU standards bodies are so far behind the curve that they now emphasize CSV (which been around since 1995 or so and formally documented in 2005 see Common Format and MIME Type for Comma-Separated Values (CSV) Files) as an indication of increasing computerization of studies: New emphasis on CSV expectations, as aspects of medical device […]
