An academic pediatric ER, opened in 85 days
Global diagnostics leader · pediatric ICU/ER blood-glucose-monitoring device study · single-site network play, live 85 days after the intro call
The challenge the client gave us
In May 2025 a global diagnostics leader brought us a study most sites would have quoted two full quarters just to open. Their point-of-care blood glucose monitoring system (BGMS) needed analytical-performance evidence — capillary and venous whole blood — from critically ill pediatric patients in both the ER and the ICU, per FDA's BGMS guidance, with the device operated by a qualified hospital operator separate from the study staff. Pediatric ICU and pediatric ER are among the hardest sites to access for any clinical study, and the guidance requires the data from exactly that population.
The catch: institutions that fit that description normally take 3–6 months to start a study. The sponsor did not have 3–6 months.
We scoped RDI's role deliberately narrow and high-leverage: find the site, make the introduction, and own the site relationship — site identification, contract and budget negotiation, and site payment management — while the sponsor ran clinical operations. The whole engagement turned on RDI's peer-to-peer MD network in hospital critical care.
At a glance
| Site opened in | 85 days (vs the usual 3–6 months) |
| Intro call → in front of first PI | Same day (May 13) |
| Health systems screened in parallel | 3 |
| Site / subjects | 1 PICU/Peds-ER site, up to 20 pediatric subjects |
| RDI scope | Site identification, introduction, contract + budget negotiation, site payment management |
| First subjects enrolled | 7 days after activation |
| Engagement growth | ~5× the original value |
Timeline
- May 13 Intro call; in front of first PI same day
- May 13–27 3 health systems screened in parallel
- May 27 Winning site qualified; NDA signed
- May 28 Startup package turned around overnight
- Jun 4 Consent forms back on site in 3 hours
- Jul 1 Sponsor site-selection letter
- Jul 10 Master agreement executed
- Aug 6 Site activated — 85 days after intro
- Aug 13 First 2 subjects enrolled
- Late Oct Pediatric cohort completes
- Nov 2025 Follow-on cohort added (in 3 weeks)
What we did as a CRO
| CRO responsibility | What RDI did on this study |
|---|---|
| Site identification | Used RDI's peer-to-peer MD network in hospital critical care to reach PICU/Peds-ER programs that don't surface on ordinary site lists; screened 3 health systems in parallel under NDA |
| Feasibility & honest read | Told the sponsor which paths were dead ends (one's internal boards met only on fixed dates; another needed EHR data before committing) and identified the one site that could actually move |
| Introduction & startup support | Made the introduction and turned the startup package around overnight (eCRF source docs, IRB approval letters, consent/assent forms, original IRB application); consent forms back on site in under 3 hours |
| Contract & budget negotiation | Drove site qualification → selection letter → fully executed master agreement and work order; negotiated the site budget |
| Site payment management | Owned the site relationship and site payments so the sponsor could keep its focus on clinical operations |
| Scope growth | Closed a follow-on critical-care cohort at the same site — revised consent, contract amendment, and central IRB approval — inside 3 weeks |
What made it hard
- The protocol needed a rare institution. Pediatric ER and ICU census and acuity, plus hospital operators willing to run the device separate from study staff — a narrow set of sites.
- Those sites are slow to open. The institutions that fit normally take 3–6 months to start a study, and the sponsor didn't have that runway.
- Some paths were structurally slow (internal boards meeting only on fixed dates; EHR-data prerequisites) and had to be identified in days, not discovered months in.
How we solved it
- We screened three health systems at once, not one after another, so dead ends surfaced in days and we could tell the sponsor honestly which paths were real.
- We moved documents in hours, not weeks — an overnight startup package, consent forms back on site the same afternoon.
- We kept the backup sites warm the entire time, so a stall would have meant a swap, not a restart.
The result
The site was activated 85 days after the intro call, on a path that normally runs 3–6 months, and the first 2 subjects enrolled a week later. The pediatric cohort completed enrollment; the sponsor then added a follow-on critical-care cohort at the same site, and the engagement grew to roughly 5× its original value. It's a working proof that site identification can be a standalone offering — RDI doesn't have to run the whole study to deliver the thing the sponsor couldn't get on its own: the right PICU/Peds-ER site, under contract, fast.
"Well, that was fast." — the sponsor's global study lead, 3 weeks into the engagement
Source: project correspondence, May–November 2025. Sponsor and site names withheld. Operations report, not a clinical-results publication.