Data standards, interoperability and regulatory assessment
When data has to move between institutions, databases and jurisdictions, the format decides whether it works. We design exchange formats, test them against the domain requirements, and build the tools that demonstrate compliance with them.
- Design and specification of exchange formats. XML schemata, ontologies and data models — agreed with expert bodies and documented so that they remain auditable years later.
- Validation tooling. Console, desktop and web service validators so that data providers can check their files themselves before submitting.
- Scientific assessment. Pharmacokinetics and pharmacodynamics from non-compartmental analysis through to bespoke models; QSAR and QSPR models for physicochemical and ADME/Tox properties, including applicability domain.
- Exposure and risk assessment for products and materials, including derivation of permitted limits and preparation for communication with authorities.
- Data curation from publications, trial registries and agency data, with documented provenance for each data point.