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The effectiveness of access controls in clinical data exchange

Sharepoint or not. Hint – not. Transferring a dump of clinical trial data?  It was recently suggested to us by a data manager, that he could share the clinical data using their Sharepoint server.   This is a very bad idea. It’s possible that the data manager’s IT manager has secured their Sharepoint server with best …

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3 things a medical device vendor must do for security incident response in a clinical trial

You have a server. You are VP R&D or CEO or regulatory and compliance officer at a medical device company. You’re doing clinical trials to validate the efficacy and safety of your connected medical device. Your medical devices measure something (blood sugar, urine analysis, facial anomalies, you name it…). The medical device interfaces to a mobile app …

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Our culture – diverse, committed and engaged with customers

Courtesy of my friend Yaron Koler — liver cancer survivor and professional software engineer It’s not about the EDC system. It’s about our values. There are 2 reasons for this: The first reason, is that today, it’s almost impossible for a tech startup to design and perfectly execute implementation and delivery of a new EDC …

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3 ways that assure protocol compliance and data integrity in your clinical trials

In this short essay,   I’ll take a closer look at how the clinical trial supply chain is evolving.  There is now rapid change from traditional site-centric trials to patient-centric operations that assure data integrity and safety monitoring We’ll see how the pandemic, innovation in clinical operations models and consumer technology drive the change to patient-centric research. …

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Github – A community of practice for the clinical trial community

Encouraging a participatory culture in clinical trials Founder and CEO of flaskdata.io, Danny Lieberman wonders if the phenomenal success of the participatory code culture on GitHub can be copied to rejuvenate the clinical trial industry and break down barriers to entry and speed up product development. Like a stranger in a strange land As a physicist and …

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High-performance clinical teams speak softly

The advantages of speaking softly I started thinking about the constraints on eClinical technology for decentralized clinical trials and patient-centric product development. The best planned patient-centric trial will not succeed if the data quality is poor at the sites. When a CRA on the team is disgruntled, it is infectious. Speed and efficiency in your …

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