Clinical research
One system for a clinical research site instead of six portals
Clinical research sites log into a CTMS, several sponsor portals, recruitment tools and a billing system every day, and coordinators re-type the same visit into most of them.
I build the site's own operations layer on top, so the work happens once, usually as a Consolidate build at $20,000.
What this usually looks like
A CTMS for studies and visits, a different EDC for each sponsor, a recruitment database, a patient-facing app, invoicing in an ERP, and Excel for anything the others miss.
Coordinators enter a visit in the CTMS, again in the sponsor's EDC, and again on the billing tracker. Recruitment numbers come from a spreadsheet someone updates on Fridays.
Across many sites, each one runs its own way, and the numbers never quite agree.
Why it got this way
Sponsors choose the EDCs, so a site can never cut those portals. What it can own is everything in between.
Site software is sold to the average site. Billing, recruitment and business development end up in separate tools because no vendor does all three the way you work.
The fix, three ways
Connect, $5,000
keep the tools, fix the plumbing
If your CTMS is solid, Connect at $5,000 links it to billing and recruitment for one workflow, so a completed visit triggers the invoice. It is the wrong choice if coordinators work around the CTMS every day.
Consolidate, $20,000
one app for the daily work, keep what still earns its place
For $20,000, I build one app for the site's daily work (visits, recruitment, billing hand-offs) that connects to the systems sponsors require. Coordinators enter a visit once.
Replace, $75,000 to $100,000
rebuild the part of the big platform you actually use
For a network of sites paying for a large platform and using a slice of it, Replace at $75,000 to $100,000 rebuilds that slice as software the network owns.
What it looks like when it's done
At CenExel Clinical Research, I was VP of Platform Enablement. The platform I supported ran billing, recruitment and business development for about 2,000 users across 18 research sites, and I launched the Platform Enablement function in my last year.
That was employed work, not a CheLabs engagement. It is why I know where a site's day goes.
Read more: selected work on the home page.
When you should not do this
If you run a single small site with a CTMS that fits, the tools you have are probably enough.
If you need something live before your next study starts in two weeks, I am the wrong fit. Connect, the fastest build, takes 3 to 4 weeks.
Questions about this
Can you integrate with our CTMS and sponsor EDCs?
With your CTMS, usually, if it has an API or exports. Sponsor EDCs are controlled by the sponsor, so they are often read-only or not open at all. Discovery confirms what each system allows before you pay for a build.
Is patient data kept secure?
Everything runs in cloud accounts your organization owns, with access limited by role and only the data each workflow needs. I work through what each workflow may touch with your compliance team during discovery, before anything touches patient data.
What experience do you have with research sites?
At CenExel Clinical Research I was VP of Platform Enablement, supporting about 2,000 users across 18 sites on a platform that ran billing, recruitment and business development. I launched the Platform Enablement function there.