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 […]

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 […]

I love being a CRA, but the role as it exists today is obsolete.

I think that COVID-19 will be the death knell for on-site monitoring visits and SDV.    Predictions for 2020 and the next generation of clinical research – mobile EDC for sites, patients and device integration that just works. I’m neither a clinical quality nor a management consultant. I cannot tell a CRO not to bill […]

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 […]

The 3 tenets for designing a clinical data management system

Abstract: This post reviews the importance of 1) proper study design, 2) good data modeling and 3) realistic estimation of project timetables. The article concludes with a discussion of eSource and attempts to dispel some of the myths including how DIY EDC study build save time (they don’t). Enjoy! The trend of DIY: good for […]

Millennials are the future of clinical trial data management

Millennials, born between 1980 and 2000 and the first native generation of the digital age, are the quickly approaching additions to the modern workforce. Regardless of whether private or public sector Millennials are soon to become the bulk of the global workforce. At present, Millennials represent 34% of the current US workforce (up 9% from […]

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? […]

How to overcome 5 eSource implementation challenges

Jenya wrote a piece about the challenges of clinical trials operations change management for regulatory people who have to work with medical technology developers and I just had to write my own intro. Frankly, its easier to talk about change for other people than for yourself. A lot easier.  I have written here, here and here […]