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 […]

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 […]

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 […]

Dealing with information junkies in decentralized clinical trials

In this essay I talk about patient-doctor asymmetry, transparency in the clinical research and clinical care,  about why secure instant messaging technology is not a always a good idea for communicating with patients and look to prospect theory for insights into how patients value information.  Do you have information junkies in your decentralized clinical trial? It happens all the […]

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 […]

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 […]

How to understand your clinical trials

In this post, I will talk about how to understand your clinical trials.
There are a number of data activities in clinical trials. You collect data from patients. The progress of a patient’s journey through the trial is monitored.

10 free ways to reduce risk in your medical device clinical trial

You cannot outsource quality in your medical device clinical trial Collecting low-quality data means that your trial is likely to fail. You will not be able to prove or disprove the scientific hypothesis of your medical device clinical trial. You will have wasted your time. You cannot outsource quality, you have to build it into […]

A better tomorrow for clinical trials

A better tomorrow – Times of crisis usher in new mindsets By David Laxer. Spoken from the heart. In these trying days, as we adjust to new routines and discover new things about ourselves daily, we are also reminded that the human spirit is stronger than any pandemic and we have survived worse. And because we […]