Safety & Pharmacovigilance

Safety & Pharmacovigilance

Connect the evidence behind every safety signal

Safety evidence is spread across spontaneous reports, trial safety data, PSMF records, and public sources, each with its own terminology. Linking drugs, adverse events, and regulatory information means rebuilding it by hand.

DISQOVER connects it all into one searchable knowledge layer, so safety teams and their AI systems work with concepts, not source-specific labels.

The data you already have

Pharmacovigilance data integration

Integrating pharmacovigilance data means connecting everything relevant to a substance's safety profile in one place a safety or risk management team can query, without replacing the source systems themselves.

You do not need new data to get value from DISQOVER: safety and pharmacovigilance teams already work with a recognizable set of public, proprietary, and licensed sources, and DISQOVER connects them.

Public data

  • Substance, product, and package identifiers: NDC, DailyMed, RxNorm, GSRS, Inxight, GUDID, SPOR, IDMP-Ontology
  • Scientific literature: PubMed, NCBI Journals, SCImago, MeSH, ORCID, PubTator
  • Clinical study registries: ClinicalTrials.gov, WHO ICTRP, CTIS
  • Adverse event data: openFDA (FAERS)
  • EU regulatory reference data: Referentials Management Service (RMS), with multilingual terms such as routes of administration and dosage forms, and Organisations Management Service (OMS) for organization data

Proprietary data

  • Suspected unexpected serious adverse reactions (SUSARs)
  • Spontaneous adverse drug reaction (ADR) reports, including post-marketing reports
  • Pharmacovigilance System Master File (PSMF) data
  • Internal clinical study data
  • Audit trails
  • Internal substance reference databases

Licensed / commercial data

  • Cochrane Library systematic reviews
  • Real-world data (RWD) databases, e.g., TriNetX, COSMOS, Flatiron Health, Tempus
  • RWD source metadata from the HMA-EMA Catalogues of Real-World Data Sources
  • EMA Summary of Product Characteristics (SmPC) documents, text-mined by a third party and made searchable

How it works

How DISQOVER approaches pharmacovigilance data integration

DISQOVER resolves two problems at once: differences in how substances, products, and adverse events are described across systems, and the relationships between safety and regulatory evidence that span domains, adding the traceability a safety decision needs on top.

Semantic mediation

XR-417 DEVELOPMENT NAME XR-417 Safety database MARKET NAME Velorex 20 mg pen Regulatory INN velorastat Literature SUBSTANCE CONCEPT Velorastat 3 names, 1 substance 14 trials · 62 adverse events Illustrative example

Cross-domain relations

Velorex PRODUCT ACTIVE SUBSTANCE velorastat DOSAGE FORM Injectable ADVERSE EVENT Injection site reaction CLINICAL TRIAL Phase 3 study LEAD SPONSOR FACILITY

Traceable provenance

ADVERSE EVENTS · VELORASTAT Injection site reaction 62 reports · 3 sources Headache 41 reports · 2 sources Nausea 28 reports · 2 sources PROVENANCE Source openFDA (FAERS) Version Quarterly release Context Linked via INN velorastat Open source record

Example questions

What you can ask DISQOVER

Products, substances, and organizations

  • How do a product family's program, development, and market names relate to its compounds, chemical names, and INN?
  • Which INN is registered for which indication, in which country?
  • Where do formulations differ for the same INN, for example a pen versus a powder and solvent?
  • Which organizations do we work with, and what are their current regulatory codes, manufacturing sites, and facility locations?

Across domains

  • Which clinical trials mention this product, who is the lead sponsor, and which facilities were used?
  • Starting from a disease, which trials address it, and how do they compare?
  • Starting from a dosage form such as injectable, which medicines, active substances, and adverse events does it connect to?

Regulatory documents and competitive intelligence

  • Which SmPC documents belong to this product, program, or INN, and how do they link to reference data such as dosage form?
  • How do EMA SmPC documents map to WHO ATC codes?
  • For osteoarthritis, which products address it, and what are their applications, dosage forms, and side effects?

Outcomes

What connected safety evidence makes possible

Safety evidence is worth most when it's connected early, and kept connected.

Safety is one of the leading causes of failure across drug development, which makes connecting safety evidence a practical necessity rather than a compliance afterthought. With DISQOVER, the data behind each of these workflows is already linked, so teams can act on the whole evidence base instead of one source at a time.

Review concomitant medications in one pass

Today, a reviewer checks each medication on a patient's list against separate label and interaction databases, one of the most time-consuming manual steps in assessing an individual case safety report. With label information and known drug-drug interactions linked to every product, the full list can be cross-referenced at once. The return is less manual checking per case.

DailyMed labels and SmPC content connect to the same canonical products and substances as your case data.

See the full picture when a signal emerges

Structured adverse event data, case narratives, trial safety data, and literature are usually reviewed one source at a time. In one connected view, patterns can surface earlier, for example a rare side effect concentrated in one patient subgroup. The return is signal assessment with the whole evidence base in view.

FAERS, your SUSARs and spontaneous reports, trial safety data, and PubMed link to the same substance and adverse event concepts.

Tell a real signal from the background rate

An adverse event can look like a signal when it is already common in the patient population. With real-world data in the same knowledge layer as spontaneous reports, the background rate becomes routine context rather than a separate study. The return is fewer false alarms taken forward to full assessment.

Licensed RWD sources, and the HMA-EMA catalogues that describe them, sit alongside your safety data.

Give prediction models connected, traceable input

Models that estimate which adverse events are more likely in a given population need harmonized input on drugs, adverse events, and patient characteristics. The knowledge graph already connects them. The return is model input your team can trace back to its source.

Provenance travels with the data, whether a model reads it through the API, an export, or MCP.

Anticipate safety findings before first-in-human

Known toxicology, pharmacology, and literature evidence for a compound's class or mechanism is spread across sources. Pulled together early, it helps a team anticipate likely findings and shape the safety monitoring plan before the first-in-human study. The return is a monitoring plan informed by evidence, not hindsight.

Early findings link to the same substance concepts you follow through post-marketing surveillance.

The same connected evidence follows a substance from early toxicology to post-marketing surveillance, so nothing is rebuilt at the next stage.

DISQOVER's capabilities

Pre-built for life sciences

DISQOVER ships with industry-standard ontologies and domain-specific entity models out of the box, so pharmacovigilance and regulatory concepts are understood from day one. For safety and pharmacovigilance, that includes:

Substance and product identifiers

RxNorm
GSRS
NDC

Regulatory and product data standards

IDMP-Ontology
SPOR
RMS
OMS

Adverse event terminology

MedDRA

Natural language search, for people and AI agents alike

DISQOVER supports natural language search directly in DISQOVER Explore. Through its MCP interface, AI agents and LLM applications can query the same knowledge layer in natural language. Either way, answers are grounded and provenance-backed.

Governed, traceable access

DISQOVER tracks which sources contributed to every data point, so visibility can be restricted by user group without separate access-management tooling, consistent across the UI and the API.

This matters when safety data carries reporting obligations and access restrictions that differ by source and jurisdiction.

FAQ

Frequently asked questions

What is pharmacovigilance data integration?

Pharmacovigilance data integration means connecting adverse event reports, clinical safety data, regulatory reference data, and scientific literature into one searchable layer, so a safety team can see the full picture for a substance without manually cross-referencing separate systems.

How does DISQOVER resolve different product and substance names across sources?

DISQOVER's semantic mediation resolves a product's development name, market name, INN, and chemical name to a single concept, so users and AI systems can search by whichever name they know and still find everything connected to it.

Can DISQOVER link a product to the clinical trials that mention it?

Yes. DISQOVER models a product's connections to its clinical trials, sponsors, and facility locations as a knowledge graph, so a user can move from a product directly to every trial that mentions it.

Does DISQOVER support EU regulatory reference data like RMS, OMS, and SPOR?

Yes. In a customer implementation, DISQOVER integrated Referentials Management Service (RMS) and Organisations Management Service (OMS) data alongside SPOR and IDMP-Ontology, aligning them to canonical product, substance, and organization concepts.

Speak with an expert

Talk to us about connecting your adverse event reports, clinical safety data, and regulatory reference data into one searchable knowledge layer.