17 pieces.
An assay validation scientist runs our trials.
Structure the CRO so the person who lives in specificity and traceability owns trial execution — not a handoff to generalists.
Right-size the validation study.
The conservative protocol that protects the filing can suffocate enrollment — scoping pre-pivotal work for evidence without theatrical burden.
Qualified site is not the same as a high-enrolling site.
Most CROs select on regulatory qualification; the signal that predicts enrollment is performance in the field, not paperwork.
Map the values, then chase them.
Value-bucket IVD recruitment: map the analytical-range distribution to populations, recruit by segment, and recalibrate weekly with the physicians who see the patients.
Patient centricity is a buzzword, not a blueprint.
Patient experience is rarely the bottleneck in IVD trials; standard-of-care-aligned design beats patient-theater checklists.
The over-engineered protocol problem.
Pre-pivotal validation protocols often recruit themselves into failure — complexity buys paperwork, not subjects.
What if I told you the secret to happiness was hard work you're good at?
Eighty thousand working hours — the culture treats them as debt against your real life; the alternative is craft you would pay to keep doing.
AI is the car. The driver is everything.
AI in clinical operations does not produce outcomes — drivers do; people and judgment remain the bottleneck.
The best sites don't have time for you. Cherish the ones that make time, and use it wisely.
A PI who has all afternoon for your diligence call is not a PI with a busy practice — the friction-rich signal is the one worth designing around.
The enrollment forecast is the only thing that matters.
Daily resolution, per-site positive-rate calibration, milestones on the calendar — updated weekly so enrollment reality stays ahead of the spreadsheet.
The best protocol is one page.
Compress ruthlessly, leave room for biological variance, and write for who actually runs the study — not the filing cabinet.
Good site qualification unravels the physician-patient relationship.
Five principles: the physician–patient relationship is the unit of analysis — and the friction that erodes it is the qualification work most CROs skip.
The sample spec sheet, and why simplicity is a feature.
One document, six tables, and roughly 25 fields — scope alignment that auto-builds the SOW because simplicity is a feature.
Give clients what they need.
Sponsor partnership as guidance — the CRO is neither order-taker nor know-it-all, but the operator who shows the path.
The case report form is a work of art.
Four principles for IVD CRF design — the case report form is the most-used UX surface on a clinical trial. Treat it like one.
Trial design framework: put physicians first.
IVD trials fail to enroll when they ask sites to do something other than care for patients. Across 300+ IVD studies since 2011, the protocols that recruit on schedule share one property: study activities fit inside the patient visit that was going to happen anyway. We call this standard-of-care alignment. Patient centricity is the buzzword; physician fit is the mechanism.
Healthy collection is the most misunderstood cohort.
Healthy is not the hardest cohort — it is the most miscategorized. Defined positively and run as a reference-range study, it becomes one of the cleanest deliverables a CRO can produce.
Conall Arora is CEO, RDI.
CEO of RDI. Acquired the company in 2017 and has led it since — the team, the systems, and the physician network that let customers of every size benefit from a specialist CRO.