What COVARIS does
COVARIS helps pharmaceutical and biotech sponsors and CROs make relevant external context visible, comparable and decision-relevant across planned countries, regions, study windows and selected assessment settings.
We translate environmental, geographic, temporal and setting-related data into practical inputs for clinical trial planning, design, evidence generation and interpretation.
Our work spans trial footprint context, participant and assessment context, and selected disease-relevant external factors.
External context data
COVARIS works with environmental, geographic, temporal and setting-related data that can be relevant to a defined clinical trial question.
Depending on the disease area, endpoint, geography and intended use, selected variables may include temperature, humidity, weather-stress indices, solar exposure or UV proxy, air pollution, PM2.5, pollen, rainfall, dampness, vegetation context, built-up intensity and urban heat.
Data sources may include Earth observation, reanalysis, climate, air-quality and other geospatial datasets.
Variables are selected during scoping when the scientific rationale, data quality and relevance to the sponsor’s question are defensible.
Grounded in ICH E5, ICH E17 and ICH E6(R3)
ICH E5 and E17 recognise that regional and extrinsic factors may influence how clinical evidence is generated, interpreted and applied across populations and geographies.
ICH E6(R3) strengthens the focus on quality by design, proportionality and the early identification of factors that may be critical to trial quality. Annex 2 addresses trials incorporating decentralised elements, pragmatic approaches and real-world data sources.
COVARIS applies this combined logic by helping sponsors identify, compare and document relevant external context across trial footprints, study windows, participant settings and selected assessment contexts.
External context screening
COVARIS assesses relevant external context across planned trial countries, regions, seasons, study windows and selected assessment settings.
The analysis is designed to identify meaningful differences, patterns and review points that may matter for trial planning, design, clinical evidence generation or interpretation.
Depending on the use case, the work may focus on the planned trial footprint, disease-relevant environmental conditions, participant settings or the context in which selected assessments and data-generating activities take place.
Designed for realistic constraints
Clinical trials are shaped by recruitment realities, required countries, regional feasibility, operational priorities and existing development strategies.
COVARIS therefore works within the sponsor’s actual constraints. The aim is not to redesign a study in the abstract, but to identify where relevant external context can inform planning, comparison and scenario assessment within a realistic trial framework.
Core delivery areas
COVARIS supports clearly defined sponsor questions across three connected areas:
Trial Footprint Context
Comparison of relevant external context across planned countries, regions and study windows.
Participant and Assessment Context
Analysis of context around home-based activities, assessments and selected digital endpoints.
Disease-Relevant Context
Focused analysis of selected external factors with a defensible rationale linked to the disease, endpoint or intended use.
The most established delivery area is Trial Footprint Context. Participant and Assessment Context is developed through bounded sponsor use cases, while Disease-Relevant Context is available within selected, scientifically supported scopes.
What a COVARIS delivery looks like
Sponsor input
The indication, development stage, planned countries and regions, study windows, assessment context, intended use and known constraints.
COVARIS analysis
Selection and comparison of relevant external context variables across the defined trial footprint or assessment setting.
Output
A concise sponsor-facing report supported by maps, profiles, dashboards or scenario views.
Readout
A founder-led discussion focused on key differences, uncertainties, review points and practical implications for planning, design, evidence generation or interpretation.
Claim boundary
COVARIS provides external context intelligence to support sponsor-led clinical trial planning, design, evidence generation and interpretation.
The analysis is designed to make relevant environmental, geographic, temporal and setting-related conditions visible and comparable. Clinical, statistical, regulatory and operational decisions remain with the sponsor and its experts.
COVARIS helps sponsors and CROs make relevant external context visible across trial countries, regions, study windows and selected assessment settings.
COVARIS does not predict outcomes or prove causal effects. It provides external context intelligence for sponsor-led planning, evidence generation and interpretation.
COVARIS ApS
2100 Copenhagen
Denmark
+45 25 30 30 28
CVR-no.: 46484673