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.
Pharmacovigilance & Medical Affairs
Case intake and coding, literature screening, signal documentation, and medical information responses that stay consistent with the approved label.
What changes on a Tuesday morning
Three examples of how the work itself changes.
Health authority query response
A query arrives with a fixed clock. The team searches across the dossier, study reports and prior correspondence to establish what has already been stated, where, and in which market. Most of the effort goes into finding and reconciling, not into deciding.
Pathology reports read,
structured and linked to source, with the abstractor reviewing instead of transcribing
faster abstraction for a top-10 pharma
Deviation triage in manufacturing
Each deviation is written up from a blank form and routed on judgement. Comparable events at other sites are hard to surface, so the same root cause is investigated more than once and precedent is lost.
Incoming deviations are matched against precedent across sites, classified with a stated reason, and routed with the supporting records attached. The quality reviewer makes the call with the history in front of them.
First-time-right result to confirm
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.
Cycle-time result to confirm
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.