Did you wait until the last minute to choose vendors for your clinical trial?

Your dream outcome. Helping cancer patients. Doing it right. Recruiting quickly and efficiently and getting a diverse population into your study. You have noble intentions and great science. So – why are you accumulating months delay even before the first patient is recruited? There are a lot of things on the science and recruitment side, […]

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 […]

Patient compliance in clinical trials – the elephant in the room

Clinical trials cost a fortune. When a patient is non-compliant during the run-in/washout period, he/she is dropped out of the study. This costs the sponsor 5X: site costs for 2 patients, recruitment costs for 2 patients and loss of time. In other words, retention is more important than recruitment. This raises the question: why is […]

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. […]

The 20M unmet needs of clinical trials according to social media and Google

If you google unmet needs in clinical trials in clinical trials – you get 20M hits. If you google “unmet needs in clinical trials” (for an exact match on the phrase) – you get 8 hits. One of the hits is from ICON (the large Irish CRO) External Control Arms Can Increase Operational Efficiency Of […]

The last mile in clinical trials

First mover advantage for clinical trials Although the notion of same day delivery seems to be recent, in fact, competitive advantage always went to those who can move quicker. Even if they are not the first. With fast communications, there is now a relentless trend towards increasing speed. We witness this trend in almost every […]

How understanding culture reduces risk in your clinical trials

It’s during the war the Russians are waging on Ukraine and I got on a thread on a blog about why Putin is so violent. I replied that from Putin’s perspective – the US and Europeans represented an existential threat to him when they pull Ukraine into NATO and when the US pushes democracy eastwards. […]

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. […]

HIPAA compliance for your clinical trials

The golden rules of HIPAA compliance for your clinical trials Flask Data provides a one-stop cloud subscription for EDC, data management and statistics. Welcome to the 21st Century – cloud, on-demand, use as much as you need and eliminate project management overheads and vendor lock-in. As Flask Data customers progress through their clinical trial journey to FDA clearance […]