One compliant platform for preclinical CROs and toxicology laboratories. Study lifecycle, the Quality Assurance Unit, test-item custody and the vivarium, with the sponsor, quotation and payment milestones purely scientific systems leave out.
Study management, the vivarium, test-item custody, QA inspections and the commercial contract usually live in separate tools, or on paper. The seams are where GLP risk, delay and cost accumulate.
Study, vivarium, test-item and QA data sit in silos, re-keyed between systems and spreadsheets.
Manual audit trails and wet-ink signatures make every inspection and reconstruction slow and risky.
Sponsor, quotation and payment milestones are disconnected from study progress and deliverables.
Draft and final reports depend on re-keying, version chaos and chasing review sign-offs.
Pick a phase to explore its stages. Each transition is captured as a 21 CFR Part 11 electronic signature and written to a tamper-evident audit trail, so directors, QA and sponsors always see exactly where a study stands.
The approved study plan is locked as the controlled version everyone works to.
Access maps to the real positions in a preclinical CRO, from Test Facility Management and the Study Director to the Test Item Control Officer, QAU and Business Development. Select a role to see what they own.
Study science, the vivarium, materials and the commercial layer, plus the lab operations that keep a facility running. All on one compliant, multi-tenant cloud.
Compliance lives in the records layer, not as a bolt-on module. Every audited action is chained to the one before it, so alteration is detectable, not merely logged.
Actor, timestamp and before/after values on every change, each entry cryptographically linked to the last.
Signer, date, time and reason bound to every controlled transition and the record it approves.
The 13-stage lifecycle and an independent QAU enforce the separation of conduct and quality assurance GLP requires.
Each sponsor's data is physically segregated, essential where one lab runs studies for competing sponsors.
Audit trail · Study TX-2026-0114
Every entry links to the previous by SHA-256 hash
Walk through the GLP lifecycle, the QAU, test-item custody and the vivarium with your own study types, in a live Fiscal Ox Preclinical Research demo.