Home alone and in a clinical trial

Decentralized clinical trials

1 in 7 American adults live alone COVID and social isolation is part of our lives. During COVID, it became easier to recruit patients for clinical trials. Like increased online shopping during social isolation of COVID?  How do deal with patients who are home alone and in a clinical trial? But — somehow, that seems […]

How to ensure patient adherence in decentralized clinical trials

patient adherence

Patient adherence in clinical trials without technology How can you assure patient adherence to the protocol, when you don’t see the patient? Life science companies are increasingly  turning to decentralized clinical trial models. This means that patients are home alone.   They use ePRO to record side effects and outcomes from the treatment. With 10X more […]

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

Phase 1 clinical trial challenges

Phase 1 challenges are unlike larger Phase 2, Phase 3 studies. The science is still unsure. The the clinical operations team at a startup may still be under construction. 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 […]

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

GCP risk

How to assure GCP for clinical trials in the best way? In this post, we will show you how to assure good clinical practice in clinical trials. According to Cancer.gov, GCP (Good Clinical Practice) is an international set of guidelines that helps make sure that the results of a clinical trial are reliable and that […]

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 […]