Clinical Trial LIS Articles & CTMS Workflows

A clinical trial LIS is a laboratory information system that runs testing under a study protocol rather than a physician’s order — tracking each specimen against its trial, visit, and study arm, and preserving the evidence a sponsor or inspector will ask for years later. The articles below cover how central labs, sponsor-affiliated bioanalytical labs, and academic research cores run that work day to day on a cloud LIS.

Trial work sits between two systems. A clinical LIS is engineered around patient orders, CLIA/CAP requirements, and billing; a research LIMS is engineered around projects, samples, and experiments. Trial labs need both at once, plus controls neither provides alone: protocol-specific workflows configured per study, high-value marker specimen handling with intact chain of custody, trial-specific billing, and the electronic-record and electronic-signature controls of the FDA’s 21 CFR Part 11 alongside ICH E6 Good Clinical Practice. The clinical LIS vs research LIMS comparison walks through where the two models diverge.

What these clinical trial LIS articles cover

The posts in this section are practical, workflow-level guides for running trial work on a modern LIS:

• Regulatory baseline — 21 CFR Part 11 controls, GCP alignment, and sponsor reporting: validated software, tamper-evident audit trails, and electronic signatures sponsors will accept. Start here.
• Sample management — specimen tracking and chain of custody across protocol handling, storage, and test history, plus the added handling that high-value marker specimens require through aliquot lineage and rule-based screening.
• Trial and project tracking — protocol-specific workflows organize accessioning and specimen handling for each research protocol, with the chain-of-custody and billing paths described above.
• Billing workflow — how clean charge data moves from accessioning into billing and clearinghouses, including eligibility checks at accessioning, CPT/ICD-10 coding, ANSI 837 claim output, and the denial feedback behind each charge.

Because trial specimens are frequently banked for later biomarker re-pull, the storage side matters as much as the run itself — see how LIMS IQ handles specimen tracking and chain of custody, the biorepository LIS workflows behind long-horizon collections, and the security and compliance controls the audit trail rests on. Labs preparing for a sponsor audit should also review the LIS validation guide.

To see protocol-specific workflows, trial specimen management, and trial billing configured against your own study, request a demo.