Data capture by sites is activity, not achievement

Never mistake data collection activity for an achievement Recruiting and caring for patients (whether at home or on site) is a research site responsibility. Capturing pages (note the paper paradigm!) is one of the key billable metrics for a site. While data collection, detection of exceptions and action to close issues are all activities essential […]

Living in an ideal world where the site coordinator is not overwhelmed by IT

Tigran examines the idea of using EDC edit checks to assure patient compliance to the protocol. How should I assure patient compliance to the protocol in my clinical trials? I get asked sometimes whether automated patient compliance deviation detection and response  is not overkill. After all, all EDC systems allow comparing input to preset ranges and […]

Are you neglecting security incident response in your DCT?

Let me ask you 3 questions.   If you answer Yes to all 3 – read this post, if not, then move on. Do you assume that your DCT  vendor has a security incident policy – based on the Web site? Are you VP R&D or CEO or regulatory and compliance officer at a drug company. […]

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. […]

If you see it in a dashboard, its too late

Thoughts on monitoring patient data and safety in clinical trials The future: tech-driven data and safety monitoring Running clinical trials with the help of tech is becoming much more prevalent, but it’s unclear if data and safety monitoring has kept up. In this essay, I discuss how patient data and safety monitoring fell behind the […]

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 […]

Help us help children with autism

You know me as a tech entrepreneur, musician and volunteer at JRV – the Jordan River village – part of the Serious Fun Network for children with serious diseases. 4 years ago I met Jenna Elbaz at JRV – Jenna was running the summer camp programs and had a dream.  Jenna brought me on board […]

How to meet the 10 top challenges in Phase 1 clinical trials

In this post, I’ll share our experiences at flaskdata.io with early stage drug and device vendors doing their first Phase 1 safety study.  You’ll see a common thread of speed and data quality. I’ll tear down the challenges for early stage life science companies into 10 parts. The 10 challenges and their solutions for early stage […]

The roles of trust, security and privacy in clinical trials

Trust, security and privacy  is a cornerstone  in clinical trials pri·va·cy/ˈprīvəsē/ The state or condition of being free from being observed or disturbed by other people. The state of being free from public attention. When it comes to clinical data there have always been two circles of trust — the trust relationship with the PI and […]

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 […]