top of page
Resources · Case Studies & Whitepapers
Evidence, frameworks, and results.
How real teams run governed AI across pharmacovigilance and clinical trials — the outcomes they reached, the frameworks behind them, and what it takes to stay inspection-ready.
Platform
Governed AI in Pharmacovigilance
A practical framework for human-in-the-loop case processing — where AI accelerates, where the human gate sits, and how to keep the whole thing audit-defensible.
WHITEPAPER · 18 PAGES · PDF
Case Study
Clinical · CTMS
Electronic Data Capture
Salvus EDC combines a no-code form designer, a declarative edit-check engine with a built-in test harness, risk-based SDV and CDISC-standard exports — built so per-study validation…
6 MIN READ
READ
Case Study
Pharmacovigilance · Crypta
Automating GVP Module VI literature monitoring
A specialty-pharma team replaced weekly manual PubMed and Embase reviews with AI relevance screening — and gained a defensible audit trail for every decision.
5 MIN READ
READ
Whitepaper
Pharmacovigilance · Signum
Signal detection at scale
Combining disproportionality analytics (PRR, ROR, EBGM) with a structured validation and lifecycle workflow — so quantitative signals lead to defensible decisions.
16 pages PDF
DOWNLOAD
Case Study
Pharmacovigilance · RMP
An inspection-ready QMS across five affiliates
How one organisation unified audits, CAPA and training across affiliates on Qualitus — and walked into inspection with the record already assembled.
5 MIN READ
DOWNLOAD
Case Study
Pharmacovigilance
Four safety tools consolidated into one database
A global marketing-authorisation holder retired a patchwork of systems for a single Salvus safety system of record — and shortened its case-to-submission cycle.
7 MIN READ
READ
Whitepaper
Pharmacovigilance · RMP
Risk-based SDV without the guesswork
A practical model for targeting source-data verification where it matters — cutting monitoring cost while holding data quality and inspection readiness.
14 pages PDF
DOWNLOAD
Case Study
Pharmacovigilance · RMP
Randomization for an adaptive Phase II in 3 weeks
Standing up adaptive randomization and multi-depot supply for a complex protocol — with blinded and unblinded roles enforced from day one.
6 MIN READ
DOWNLOAD
Whitepaper
Pharmacovigilance · RMP
From documents to data: rebuilding the RMP
Why the document-centric risk management plan breaks at scale, and how a structured-data model makes safety concerns and minimisation measures reportable by default.
12 pages PDF
Case Study
Pharmacovigilance · ICSR
Replacing a legacy safety system, zero gaps
A phased migration off a legacy ICSR database to Salvus — with parallel running and no missed expedited-reporting deadlines through the cutover.
5 MIN READ
READ
Whitepaper
Pharmacovigilance · RMP
Part 11 & Annex 11: an audit-trail checklist
What an inspection-ready audit trail must capture when AI is in the loop — a practical checklist mapped to 21 CFR Part 11 and EU Annex 11
10 pages PDF
DOWNLOAD
Stay current
New case studies and papers, in your inbox.
Occasional, substantive updates on governed AI in drug development — no noise. Unsubscribe anytime.
bottom of page