Is social networking a threat or an opportunity for patient compliance?
How social networking helps medical device clinical trials achieve high rates of recruitment and patient compliance.
The role of your biostatistician for success in medical device clinical trials
The importance of biostatistics in medical device clinical trials In order to understand the importance of biostatistics in medical device clinical trials we talked to Dr. Lisa Deutsch. Lisa Deutsch, Ph.D is a Managing Partner at BioStats Statistical Consulting Ltd. Lisa is one of the rare breed of biostatisticians that are specialized practitioners in biostatistics […]
Strong patient adherence in real life starts with strong people management
Patient adherence in real-life starts in clinical trials determining the safety, side effects and efficacy of the intervention, whether a drug or a medical device. Like any other industry – success in clinical trials is all about the people. The hugely successful movie – “Hidden figures” tells the story of the gifted black women mathematicians […]
Medical device clinical trials – not for the faint of heart
Patients in medical device clinical trials are on their phones. On their phones for WhatsApp and for monitoring chronic conditions and reporting outcomes at home, at work and in the middle of a call to their friends. Medtech developers are looking to make their product development process as effective as possible and are facing conflicting requirements when it […]
Risk based monitoring. It’s about the people.
It will come as no surprise to anyone who is actively involved in clinical trial operations that the heart of the matter in clinical trial monitoring is people. I have written here, here and here about how people are the key assets and vulnerabilities in medical device clinical trials. Understanding people and providing timely and high-quality communications rests is a key to […]
Important EDC features for medical device clinical trials
Medidata Rave and its CTMS companion product iMedidata are a far more comprehensive solution than OpenClinica but when you choose EDC software for medical device clinical trials, you enter a realm of unique requirements involving connectivity, security, privacy, API integration and specific interfaces to hardware. Electronic data capture software (EDC software) systems have demonstrated that […]
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 […]
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 […]
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? […]
