For clinical affairs
It's wired into the design, the risk, and every claim you make. Change the evidence, and you see exactly which claims and which parts of the file move.
Intended purpose ↔ design ↔ evidence ↔ benefit-risk, linked; the CER is a living document over the system of record, never a stale snapshot. Documents →
Every marketing and labeling claim is an item linked to its substantiating evidence and within cleared intended use; change the evidence and see which claims are now unsupported.
Systematic search against PubMed, ClinicalTrials.gov, Embase, and the Cochrane Library, executed from inside the evaluation; citations resolved via CrossRef; every appraisal cites its source. Integrations →
Sites, monitoring, safety reporting, and device accountability at the aggregate level, feeding the evaluation; PMCF closed-loop into PMS and vigilance.
A literature appraisal updates or a study result lands. Instantly see which marketing and labeling claims it supports, or no longer supports, and which parts of the CER and technical file are affected. Overclaim becomes a controlled, auditable process instead of a liability.
No, and by design: Avera runs study operations, evaluation, and evidence; patient data stays in the site's clinical systems.
Search, appraisal, and evidence synthesis with named sources; let's confirm depth against your device.
It's authored and maintained as a living document tied to source, frozen and signed at review; we'll walk your reviewers through it.