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Discover our latest articles and blogs
Risk-Based Monitoring Labs: What a Lab Partner Must Deliver
How a laboratory supports risk-based monitoring in clinical trials: critical lab data, thresholds, specimen logistics, and what CROs and sponsors should ask a lab.
Part 11 Lab Data: What Counts and How to Prove It
Part 11 lab data explained for practices, CROs and sponsors: which lab records fall under 21 CFR Part 11, what FDA expects, and how to vet a lab partner.
SDTM LB Mapping: A Practical Guide for Lab Data
How to map laboratory data to the SDTM LB domain: LOINC, units, the FDA LC domain, CDASH planning and the deliverables reviewers expect.
Imaging vs Blood Biomarkers: Two Thresholds Shape Clinical Triage
Compare blood and imaging biomarkers, assess performance and gray zones, and build a staged clinical workflow with lab capabilities for implementation.
Imaging Charters for Trials: Turn FDA Guidance Into Site Checks
Learn how sponsors turn FDA imaging guidance into charter requirements for site certification, MPE oversight, DICOM to EDC workflows, and central lab support.
Reference Range Harmonization: 4 Checks Before Labs Share an Interval
Learn when reference range harmonization fits, what laboratories should check first, and how standards and multicenter evidence shape verification plans.
DICOM SR for Trials: 5 Checks for Traceable SDTM Mapping
Configure DICOM SR templates for trials with five practical checks, TID 1500 measurement reports, and CDISC SDTM mapping to keep findings traceable.
CDASH Mapping: Get LBLOINC Right for SDTM Lab Submissions
Prepare lab data for SDTM submission with documented mappings, traceable ETL rules, LOINC coding, validation checks, and a practical lab partner workflow.
Radiology Data QC for Research Teams: From MRIQC to Audit Scripts
Turn radiology data QC protocols into scripts for research teams, with provenance checks, DICOM audits, image review, annotation QA, and release gates.