Governed data for research, regulatory, and safety
Life sciences data teams manage more external standards than any other sector, and every one of them releases on its own clock. TopQuadrant governs the terminologies, product data, and research metadata underneath discovery, submission, and safety, so a standards release is a review rather than a remediation project.
Trusted across life sciences
GSK, Merck, Abbott, AbbVie, and Stryker build governed data foundations on TopQuadrant.
The pressures life sciences data teams face
Standards releasing faster than governance can absorb, regulators asking for structured data instead of documents, and AI programmes blocked on research data nobody can find.
Standards churn on twelve clocks
SNOMED CT now releases monthly, RxNorm always has, MedDRA twice a year, and LOINC goes monthly in 2027. Each release retires concepts your mappings depend on, and there is no unified standards calendar to plan against.
Regulators now want structured data
ISO IDMP and EMA’s Product Management Service require products, substances, and organisations as structured, identified data. Most of that information still lives as narrative text in an SmPC and in systems built to manage documents.
Three submission regimes at once
PMDA has mandated eCTD v4.0 since April 2026, the EU is targeting Q3 2026, and the FDA remains voluntary. One global product data model has to serve all three or you maintain three and reconcile forever.
AI programmes blocked on findable research data
Discovery data exists but is not described, and the ontologies that would explain it sit in project folders. Data standards and ontologies are the most commonly cited gap preventing research data from being FAIR.
A platform that delivers results
When research, regulatory, and safety teams work from one governed set of standards, the same release stops costing four separate remediation efforts.
Where TopQuadrant fits in life sciences
The use cases financial data, risk, and governance teams run on TopBraid EDG.
Built on the standards your regulators already know
Open W3C standards underneath, and the industry’s own vocabularies on top, so nothing you model is locked to us.
Browse the resource hub →ISO IDMP
Identification of medicinal products
ISO 11615, 11616, 11238, 11239, and 11240 modelled together and resolved against EMA’s SPOR referentials.
SNOMED CT & MedDRA
Clinical and safety terminology
Import each release, see what changed, and know which of your mappings and datasets it affects.
CDISC
Submission data standards
SDTM, CDASH, and controlled terminology governed alongside your divergences from them.
HL7 FHIR
Terminology and product resources
Publish governed vocabularies as CodeSystem, ValueSet, and ConceptMap resources for FHIR consumers.
The questions a life science team actually gets asked
Each one needs a governed answer that carries its definition and its lineage, not a best guess from a warehouse query.
“A terminology release used to consume a week and end in an argument. It is now a review queue with an owner.”
More reading
Guides, sessions, and field notes for financial services data teams.
View all →What supervisors mean by sustained remediation
Reading the recent BCBS 239 findings as a data architecture brief.
WebinarSemantic layers that agents can actually use
Why constrained query construction beats a better prompt.
BlogWhat FIBO actually gives you
Where the standard helps, and where you still model your own.