How to secure your data in mobile medical device clinical trials
So you are getting ready to run medical device clinical trials with your mobile medical app or a medical appliance that is connected to the Internet via Wifi in the patient’s home network. How do you secure your device and your cloud systems and how do you comply with the HIPAA Security Rule that is a […]
Homeostasis and medical device clinical trials
Danny talks about how to strike a good balance between people and technology for monitoring medical device clinical trials. Are real-time alerts too much of a good thing for monitoring your study? Maybe real-time alerts for patient compliance in medtech studies is just a fad – a fad just like WhatsApp. I had a conversation […]
Why medical IoT is outside your comfort zone
Connected medical devices or (medical IoT – Internet of Things) outnumber people. This is an article David wrote about 1.5 years ago. It is a good general introduction for the layman to the challenges of developing connected medical devices in clinical trials but it is not a technical treatment and doesn’t get into the really […]
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 […]
why a medical device is now the biggest risk in your clinical trial
Of all of the connections brought about by the Internet of Things, nothing is more frightening than the notion of an unsecured medical device. The magnitude of risk associated with medical devices and the Internet of Things is a gripping proposition with 67% of medical device makers expecting an attack on their devices while only […]
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 […]
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 […]
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, […]
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 […]
