Lara Flores
COO of RDI. An assay validation scientist who runs the trials — sample collection teams and the CLIA lab.
The person who runs the trials.
Leads all operations at RDI — sample collection teams and the CLIA lab. Most recently ran Global Lab Operations at NeoGenomics. Before that, business services and clinical operations at Beaufort, an IVD CRO. B.S. in biochemistry from UCLA. Developed and validated 80+ assays across a career at LabCorp, Genzyme, One Lambda (Thermo Fisher), Pathway Diagnostics (Quest), and Amgen.
What she publishes.
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.
Talk to the person who would run your study.
Replies come from the team that scopes and executes the work.