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 […]

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 […]

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 […]