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 […]
What real-time data and Risk-based monitoring mean for your CRO
A widely neglected factor in cost-effective risk-based clinical trial monitoring is availability and accessibility of data. RBM methods used by a central clinical trial monitoring operation that receives stale data (any data from patients that is more than a day old is stale) are ineffective. Every day that goes by without having updated data from […]
The 3 tenets for designing a clinical data management system
Abstract: This post reviews the importance of 1) proper study design, 2) good data modeling and 3) realistic estimation of project timetables. The article concludes with a discussion of eSource and attempts to dispel some of the myths including how DIY EDC study build save time (they don’t). Enjoy! The trend of DIY: good for […]
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 […]
Millennials are the future of clinical trial data management
Millennials, born between 1980 and 2000 and the first native generation of the digital age, are the quickly approaching additions to the modern workforce. Regardless of whether private or public sector Millennials are soon to become the bulk of the global workforce. At present, Millennials represent 34% of the current US workforce (up 9% from […]
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 […]
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 […]
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 […]
