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 […]

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 […]

So what’s wrong with 1990s EDC systems?

Make no doubt about it, the EDC systems of 2020 are using a 1990’s design. (OK – granted, there are some innovators out there like ClinPal with their patient-centric trial approach but the vast majority of today’s EDC systems, from Omnicomm to Oracle to Medidata to Medrio are using a 1990’s design. Even the West […]

Competitive buzzwords in EDC companies

We recently did a presentation to a person at one of the big 4 pharma.  His job title was Senior IT Project Manager Specialized in Health IT. I looked at the persons LinkedIn profile before the call and I noticed that the sentence is in past tense. Specialized in Health IT implying that he was […]

The gap between the proletariat and Medidata (or should I say Dassault)

We need a better UX before [TLA] integration The sheer number and variety of eClinical software companies and buzzwords confuses me. There is EDC, CTMS, IWRS, IVRS, IWRS, IRT, eSource, eCOA, ePRO and a bunch of more TLAs. For the life of me I do not understand the difference between eCOA and ePRO and why […]

What real-time data and Risk-based monitoring mean for your CRO

A widely neglected factor in cost-effective risk-based clinical trial monitoring is availability and accessibility of data. RBM methods used by a central clinical trial  monitoring operation that receives stale data (any data from patients that is more than a day old is stale) are ineffective. Every day that goes by without having updated data from […]

Implementing an EDC to take advantage of risk-based monitoring

Clinical trial monitoring is 30-40% of your project costs.    At least half of that cost is manual work and SDV activities which can be eliminated with use of modern technologies like electronic source documents and remote risk-based monitoring. In this post, we take a look at how you can automate routine data management activities […]

Homeostasis and medical device clinical trials

Danny talks about how to strike a good balance between people and technology for monitoring medical device clinical trials. Are real-time alerts too much of a good thing for monitoring your study? Maybe real-time alerts for patient compliance in medtech studies is just a fad – a fad just like WhatsApp. I had a conversation […]

The great ripoff of SDV in medical device studies

Question Are you still doing 100% SDV in your medical device clinical trial? Here are some facts from medical device clinical trials: 30% of your study budget is for monitoring and 50% of monitoring is for SDV For a $1M study – you are spending $150k for SDV. What do you get for your $150K? […]