Clinical research is coordinated work across sponsors, sites, CROs, monitors, and auditors, each contributing to the trial through their own systems and timelines. LabRelations is built for the people running the trial: CTMS for studies, sites, and milestones; EDC for clean data capture; eTMF that builds itself as the trial runs. QMS handles SOPs, training, and the quality records that sit around the trial. If you also operate a central lab, LIMS fits alongside.
The trial team works in software designed for trials, and QA works in software designed for quality. Each is built for the people using it, and they share the same trial data underneath. GCP, ICH E6 (R3), 21 CFR Part 11, and ALCOA+ are built into every action, exportable, filterable, and inspector-ready.
CTMS, EDC, and eTMF for running trials. QMS for the SOPs and training that sit around them. LIMS if you also run a central lab.
CTMS for studies, sites, subjects, visits, and milestones. EDC for eCRFs and edit checks. eTMF that builds itself as documents are generated. Sponsors, CROs, and sites work off the same record instead of trading versions over email.
They share subject, site, and visit data. A subject visit logged in CTMS opens the right CRF window in EDC. A query raised in EDC shows up against the right subject in CTMS. There's no nightly reconciliation job.
Documents land in the right zone automatically. Define the TMF reference model once; the system files things from there. By the time of inspection, the TMF is already organised, not assembled from a SharePoint dump the week before.
QMS handles documents, SOPs, training, deviations, change control, and CAPA. QA and training leads work in it independently of the trial systems, but they share the same identity and audit framework. SOP reads by site staff get logged the same way as study actions.
Only if you have one. LIMS is a separate platform for sample handling, testing, and CoAs. It plugs into the trial data when it's there, and stays out of the picture when it isn't.
Audit trails on every action. Electronic signatures inline with the work. Role-based access by site, study, and role. The audit trail is exportable for inspectors and filterable by user, time, and object.
Yes. CRFs, edit checks, monitoring plans, and approval routes are built in the UI by your study build team. No code, no waiting on a vendor build cycle. Configuration sits inside the validation envelope.
