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Use Cases

Where Axenivo Helps Across the Pipeline

From discovery to safety, every workflow answers the same way: observation kept separate from interpretation, a stated confidence, a citation to your own SOP, and a named expert who decides.

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Example Outputs

Illustrative answers on synthetic data, with the route each request took.

Input

Spontaneous adverse event report from your safety inbox

Private AIConfidential data: stays in your cloud

Case AE-26-0418 Synthetic example
FieldReported
Suspect drugAXV-201, 20 mg
EventLiver enzymes raised
OnsetDay 34 of treatment
OutcomeRecovering after stop
Safety scientist

Process this case against our case-processing SOP.

Axenivo Draft for expert review
Observation
ALT 5.2× the upper limit of normal on day 34, with normal bilirubin; the drug was stopped and values are falling.
Interpretation
Possible drug-induced liver injury. The event is not listed in your reference safety information; no seriousness criteria are met on current information.
Confidence
Moderate. Concomitant medications are only partly reported.
Grounded in your SOP
Case-processing SOP PV-012, seriousness and expectedness assessment (section 5.3), and the current reference safety information.
Safety scientist action
Safety scientist confirms the coding and assessment, requests follow-up information and decides the reporting timeline.

Illustrative examples with synthetic data. These are not real patients, compounds, studies or model output; they show the format of Axenivo’s answers. Document names and sections are examples of your own SOPs.

Workflows by Team

Most organisations start with one of these. Each runs where it belongs: private for confidential data, managed for public sources.

Drug Safety

Safety case intake and narratives

Who uses it
Safety scientists and physicians
Input
Adverse event reports from your safety inbox, literature and partners
Output
Coded case draft, seriousness and expectedness notes, narrative draft
Grounded in
Your case-processing SOPs and reference safety information
Route
Private AI
Human decision
Coding, assessment and reporting timeline

Clinical Development

Clinical study report drafting

Who uses it
Medical writers and clinical scientists
Input
Source tables, listings and the protocol
Output
CSR section drafts in your template, with every number traced to its table
Grounded in
Your CSR template and writing style guide
Route
Private AI
Human decision
Every statement, especially statistical claims

Regulatory Affairs

Submissions and agency responses

Who uses it
Regulatory writers and leads
Input
Agency questions, your data and prior dossiers
Output
Draft CTD sections and response letters with cited sources
Grounded in
Your prior responses and regulatory SOPs
Route
Private AI
Human decision
Content, sign-off and submission

Discovery

Compound and assay analysis

Who uses it
Medicinal chemists and biologists
Input
Assay results and structures from your screening database
Output
Series summaries and ranked candidates against your target profile
Grounded in
Your target product profile and lead-selection criteria
Route
Private AI
Human decision
Which compounds to make and test next

Intellectual Property

Patent landscape and FTO scans

Who uses it
Patent counsel and IP scientists
Input
Your invention disclosures, compared with public patents
Output
Overlap summaries and claims flagged for a closer look
Grounded in
Your IP search protocol and claim-comparison template
Route
Private AI
Human decision
Whether a formal opinion is needed

Research Operations

Literature-to-protocol matching and lab notebooks

Who uses it
Scientists and study teams
Input
New publications (public) and your protocols and notebooks (private)
Output
What changed in the literature and which protocols it affects; structured notebook entries
Grounded in
Public sources for summaries; your protocols and SOPs for the mapping
Route
Managed AI for public text, private AI for the mapping
Human decision
Relevance and any protocol change

Questions Teams Ask First

Drug safety “Is this case serious, and is it expected?” Grounded in: Your case-processing SOPs and reference safety information. Private AIPilot-ready Clinical operations “Summarise the protocol deviations from this site.” Grounded in: Your monitoring plan and deviation SOP. Private AIPilot-ready Medical writing “Draft the CSR results section in our template.” Grounded in: Your templates, style guide and source tables. Private AIPilot-ready Regulatory affairs “Draft a response to this agency question.” Grounded in: Your prior dossiers, responses and regulatory SOPs. Private AIPilot-ready Discovery “Which compounds in this series fit our target profile?” Grounded in: Your assay data and lead-selection criteria. Private AIPilot-ready IP and patents “Does this disclosure overlap with published patents?” Grounded in: Your disclosures, compared with public patent data in your cloud. Private AIValidation first Quality and GMP “Which SOPs does this deviation touch?” Grounded in: Your quality system, SOPs and batch records. Private AIPilot-ready Literature “What’s new on this target this month?” Grounded in: Published literature and public trial registries. Managed AIPilot-ready Competitive intelligence “Summarise competitor pipeline news this quarter.” Grounded in: Public pipelines, press releases and conference abstracts. Managed AIPilot-ready Every team “What does our SOP say for this situation?” Grounded in: Your SOPs, work instructions and templates. Private AIPilot-ready

Axenivo supports scientific, safety and regulatory work. It does not make decisions: a qualified expert reviews every output, and nothing is submitted or reported automatically.

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Tell us which workflow costs your experts the most time. We will scope a supervised pilot around it.

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