Ready for an eSource and automation solution at your Clinical Pharmacology Research Unit?
Wish I had as much hair as some of these guys!
I am a huge fan of eSource & automation software in Early Phase (‘Phase I’) trial settings and have been working with them for more than 20 years now.
In early articles I have written about eSource Stakeholders, What is eSource and how is it different to EDC?, and eSource Systems - what’s included?.
I do have a bias in that almost all my experience has been working in, or with, Contract Research Organisation (CRO) clinical pharmacology research units conducting commercially sponsored clinical trials.
I am not trying to put smaller, academic sites off from going paperless - you should!
As fast as you can!
There are eSource software solutions out there that will suit all types of trial sites, some are ‘heavier’ than others. Some can be used tactically, like sponsor provided EDC / eCRF solutions, on this trial but not that one.
Others, the ‘heavy’ ones, are intended to be used as your sites’ operating platform for clinical research.
When deployed and used properly they will be vital for sustaining quality and preventing errors, not just helping to identify and document errors after the fact.
It’s very hard to quantify the cost of errors and rework, and few sites consider this when thinking about the Return on Investment (ROI). They focus on calculating time saved and efficiency. I know CROs sites that have had to re-run entire cohorts of a trial due to doubt placed on pharmacokinetic (PK) blood sample processing workflows. That’s a very expensive mistake in terms of cash and reputation or brand.
eSource and automation software won’t make you bulletproof and cannot prevent all types of errors. Due to poor blood sampling technique you can take every sample on time, and process them all perfectly, but still have unacceptable levels of haemolysis that seriously impact the ability to quantitate levels of drug and metabolites in the plasma. As always, staff training is critical.
I am presenting a brief checklist to help sites determine if they are ready to adopt an eSource an automation solution in their Phase I clinic…
You do commercial, early phase clinical research (principally healthy volunteer clinical trials)
You run multiple trials concurrently and have cohorts consisting of 6+ participants included and treated on the same day (bioequivalance and other trials are likely to have much larger cohort sizes, but are often inherently less risky, and often much simpler than e.g. Single Ascending Dose (SAD), Multiple Ascending Dose (MAD) multipart protocols)
You will have participants from multiple trials in house for extended stays
You have experience of vendor management and due diligence for complex technology vendors
You have experience of computer systems validation, change management and IT project management
You have the commitment to execute a 6-12 month onboarding project (depending on scope)
You are willing to consider taking the software ‘out-of-the-box’, making minimal change requests in the first phase of operational delivery
You are willing to consider addressing your ‘must have’ requirements in the first phase of the onboarding project, and will come back in ‘part 2’ for the ’should haves’. You are prepared to live without your ‘nice to haves’
You have done your homework, done your ROI calculations and made the decision to switch from paper to eSource / or need to switch away from an existing eSource vendor or solution
Your sponsors’ expect you to use eSource and automation to deliver the highest quality trial data, in the quickest times at an affordable price
You have funding for the implementation project and ongoing costs
You have a start date in mind
Love to hear from you whether you do or don’t agree!
