How to meet the 10 top challenges in Phase 1 clinical trials
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
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 […]
Why you do not want to unify data in your clinical trial
Unified clinical data sets – good or bad? Unification of data from patient medical records, hospital reports and clinical trial protocols is a tempting yet extremely dangerous idea. In this outstanding guest post, security and privacy expert, Veronika Valdova from Arete-Zoe explains why merging medical records, hospital reports, and clinical trial data is a very bad idea. How data breaches […]
Career development for clinical data managers
A good clinical data manager is an essential piece of running a clinical trial. A well-trained and responsibility clinical data manager is a an important part in study execution. A good clinical data manager will want to have a career development plan. A clinical data manager on an individual contributor track, needs to develop […]
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 […]
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 […]
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. […]
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 […]
Our culture – diverse, committed and engaged with customers
Courtesy of Yaron Koler. 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 or decentralized clinical trials system which does not have a […]
Streaming clinical trials in a post-Corona future
Last week, I wrote about using automated detection and response technology to mitigate the next Corona pandemic. Today – we’ll take a closer look at how streaming data fits into virtual clinical trials. Streaming – not just for Netflix Streaming real-time data and automated digital monitoring is not a foreign idea to people quarantined at […]
