By Jim Kremidas, AMRC Executive Director
Ask ten people in clinical research about what makes a good site, and you’ll get ten answers. Ask how they’d prove it and most will go quiet.
That’s what our 2025 industry consultation set out to test. We asked MCRCs, Sponsors, CROs and technology partners how quality is defined, how it’s assessed, and how it’s perceived. On one point, the answers lined up. Everyone cares about quality. Almost no one measures it the same way.
Quality is judged on the wrong things
Sponsors told us what they value most is reliable delivery: sites that start on time, enroll the patients they commit to and keep them in the study. But there’s no agreed way to measure that, so quality ends up judged on proxies and on reputations built one study at a time. Sites, for their part, have no common yardstick to show what they deliver.
It’s a gap the whole industry already feels. It slows site selection, makes performance hard to compare and leaves good sites hard to tell apart from the rest.
Two working groups, one shared goal
To close it, AMRC set up two quality working groups, each bringing MCRCs, Sponsors and industry participants to the same table.
The Systemic Quality Working Group, chaired by Jennifer Byrne, CEO of Javara, and AMRC member, is building the Network Reliability Score. It measures quality at entity level, looking at the systems and processes an organization runs across its sites rather than any single site’s results.
The Sites and Patients Quality Working Group, chaired by Carlos Orantes, CEO of AMRC member Alcanza Research, is building the Site Performance Standard (SPS). It measures quality where trials actually happen: at the site, and in the experience of the patients taking part.
Participants include MCRCs Javara, Panthera, K2, Objective Health, Alcanza Research, DM Clinical and AMR Clinical; Sponsors GSK, Novo Nordisk, Takeda and Boehringer Ingelheim; and Duke Clinical Research Institute and MedEvidence, with input from FDA reviewers.
A standard for every site
The SPS was built by MCRCs, but it isn’t only for MCRCs. Its metrics focus on what every site has to get right: starting studies on time, enrolling and retaining patients, and running consistently. Those apply just as much to independent sites, academic centers, hospital research units and networks.
Any site can use the SPS to benchmark itself. Any Sponsor can use it to compare sites on the same terms. That’s the point of a standard. It only works if it’s shared.
What happens next
Both standards are in their first iteration. We’re now in further consultation with Sponsors and regulators, testing the measures against how they’re actually used in site selection and oversight. We’ll publish both standards very soon.
From there, the focus moves to adoption: working with MCRCs, Sponsors and sites to put the measures into practice, and improving them as the evidence comes in.
Join the conversation at ING
Jennifer and Carlos will present both standards at the Innovation Network Gathering (ING) Roundtable in Philadelphia, 6-7 October, followed by an AMRC deep dive session with Sponsor and industry stakeholders. If you’re there, come and tell us where the measures work and where they don’t.
Quality has been everyone’s priority for a long time. It’s time it was something we could all measure.
