11 pieces.
Monitoring is evidence-gathering.
IVD monitoring as investigation in service of a regulatory story — four principles for what “monitoring” should produce.
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.
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.
We make our own kits.
Kit-making controls enrollment timing, supports sites operationally, and locks in sample quality — three principles for IVD logistics.
Kickoff documents are how projects get managed.
The kickoff document is not a meeting agenda — it is the artifact the team operates from for the life of the study.
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.
The 20-minute SIV.
The SIV is a milestone, not the work. Good site support is a system that runs continuously — before activation, during enrollment, after database lock.
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.
Gantt charts are not project managers.
Real PMs find dry ice for sites at 6 a.m. Gantt charts are tools, not work — what IVD operations leadership actually looks like on the ground.
Lara Flores is COO, RDI.
COO of RDI. An assay validation scientist who runs the trials — sample collection teams and the CLIA lab.