Decisions you can defend, reached sooner
Visium builds AI into your regulated workflows, validated with your quality organisation and deployed in your environment. Every output traces back to the document, section and version it came from, so your reviewers and auditors follow the same evidence your team did.
Pathology report intelligence: 90% faster abstraction at a leading Pharmaceutical Company
The bottleneck is rarely the science. It is the evidence around it
Four forces shape almost every conversation we have with biopharma teams. Each one is a documentation and data problem before it is a technology problem.
Regulatory burden
Submission and safety documentation grows with every market, variation and signal. Volume rises. The quality expectation does not decrease.
Review and rework cost
Every review cycle spends time and budget. When a document goes back for rework, the delay lands on filing dates, batch release and query response windows.
Fragmented data
One decision draws on study reports, safety databases, manufacturing records, quality systems and thousands of PDFs. Confidence drops at every manual hand-off.
AI without breaking GxP
Leadership asks for progress on AI. Quality asks who validated it and how it is controlled. Most pilots stall in the space between those two questions, which is where we start.
Validation is the first design constraint, not the last approval
Your quality function sees the intended use, the risk assessment and the test approach before development starts. That is what makes the output usable in a regulated process.
Qualified by design
Documented intended use, risk assessment, test evidence and change control, agreed with your quality organisation and aligned to your existing validation approach. Model behaviour is specified and monitored, not assumed.
Human in the loop
Human oversight is built into regulated workflows. The system retrieves, drafts, compares and flags, while reviewers validate outputs where required. Accountability remains with the appropriate expert, with the interface designed to make review focused and efficient.
Traceable to source
Every statement links back to the document, section and version it came from. A reviewer can see where a claim comes from without leaving the screen, and the audit trail is a by-product of normal use.
Your environment
Deployment in your cloud tenancy or on premise, inside your identity and access model, with data residency you control. Nothing regulated leaves the perimeter you have already qualified for.
Where your cost and cycle time actually sit
Each page covers the decisions in scope, how the work changes, what evidence is produced and what validation looks like.
Drug Discovery
Triage, prediction and evidence assembly that shorten the list, expose liabilities earlier, and leave a rationale someone can follow 12 months later.
Manufacturing Operations
Batch record review, deviation handling at the line, tech transfer documentation, and the analysis behind yield and capacity decisions across sites.
Quality & Compliance
Deviation and CAPA triage, SOP and change control, complaint handling, and continuous audit readiness across a document estate nobody can read end to end.
Regulatory Affairs
Submission authoring support, variation management, health authority query response, and label change impact across markets and product families.
What changes on a Tuesday morning
Three examples of how the work itself changes.
Pathology report abstraction
Reports arrive from hospitals in dozens of different formats, with no consistent structure. Extracting structured information means reading each document from end-to-end, and the findings are subject to interpretation.
Pathology reports read, structured and linked to source, with the abstractor reviewing instead of transcribing
faster abstraction for a top-10 pharma
Comparative evidence in market access
Patient-reported outcomes are the measures that matter in insomnia. They are also the measures that conventional real-world evidence cannot see. PROMs are rarely captured in structured data, so the usual RWE methods have nothing to compare.
Clinical notes read for signs of daytime impairment, with treatment effects compared across therapies on real-world data instead of a trial per competitor
of its kind, peer-reviewed in Nature
Screening triage in discovery
Hit lists are prioritised on activity, and developability or ADMET liabilities appear later in the programme, once time and material have already been committed.
Candidates are assessed on predicted developability and ADMET alongside activity, so the liability shows up while changing direction is still cheap.
new biomarker candidates identified
Built for the frameworks your auditors already use.
Every deployment is scoped against your quality system and your security review before a line of production code is written.