Patient compliance

Innovative clinical trial data management

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 …

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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 …

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patient compliance in medical clinical device trials

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 …

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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 …

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GCP for clinical trials – patterns of low-concern and high-impact

Today I want to talk about  “anti-design-patterns”  in GCP (good clinical practice) for clinical trials. In architecture and software engineering, a design pattern is a generalized and repeatable solution to a problem. You can think of a design pattern as a template for how to solve a problem, build a house, construct a piece of …

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clinical data management

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, …

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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 …

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