What COVARIS does
COVARIS helps sponsors and CROs screen planned clinical trial countries, regions and enrollment windows for disease-relevant environmental instability before protocol lock.
The focus is planning-stage decision support. COVARIS helps make environmental variation explicit, comparable and relevant to discussions about exposure adequacy, endpoint variability, trial risk and study robustness.
Environmental extrinsic factors
COVARIS focuses on environmental extrinsic factors that can be assessed through public Earth observation, reanalysis, climate, air-quality and related environmental datasets.
Depending on disease area, geography and study window, sponsor-scoped variables may include temperature, humidity, weather-stress indices, solar exposure or UV proxy, pollen, air pollution, PM2.5, wildfire smoke, rainfall, dampness, vegetation context or urban heat proxies.
Variables are not included automatically. They are selected during scoping when the disease rationale, data quality and trial-planning relevance are defensible.
Grounded in ICH E5 and ICH E17
COVARIS is grounded in the planning logic of ICH E5 and ICH E17. These guidelines recognize that intrinsic and extrinsic factors can matter for how clinical data are generated, interpreted and applied across regions.
ICH E17 specifically states that regional variability, the extent to which it can be explained by intrinsic and extrinsic factors, and its potential to influence study results should be carefully considered at the planning stage of multi-regional clinical trials. It also notes that the magnitude of such variability may be examined in exploratory studies before confirmatory MRCT design.
COVARIS focuses on one underdeveloped part of that planning question: environmental extrinsic factors that can be profiled across countries, regions and study windows before protocol lock.
Pre-protocol environmental screening
COVARIS screens planned trial footprints before protocol lock. The analysis compares selected environmental variables across countries, regions, seasons and enrollment or assessment windows.
The purpose is to identify whether the planned footprint appears environmentally stable, uneven or exposed to contextual instability that should be considered before key geography and protocol assumptions are locked.
Designed for realistic constraints
COVARIS does not assume that sponsors can freely redesign a clinical trial geography. Real studies are shaped by recruitment realities, operational constraints, required countries, regional feasibility and commercial priorities.
COVARIS is therefore framed as decision support under constraints, not abstract optimization.
Main service
The main COVARIS service is planning-stage environmental screening of a proposed clinical trial footprint.
The output is a sponsor-facing assessment of whether the planned countries, regions and enrollment windows appear environmentally stable, uneven or exposed to contextual instability that may matter for exposure adequacy, endpoint variability or study robustness.
While the current commercial focus is pre-protocol environmental screening, the same analytical foundation may also support scoped realized environmental context around trial geographies during or after study conduct.
What a COVARIS delivery looks like
Sponsor input
Indication, development stage, planned countries and regions, enrollment window, endpoint context and known constraints.
COVARIS analysis
Screening of disease-relevant environmental variables across the planned trial footprint.
Output
A sponsor-facing screening report and readout.
Readout
Environmental stability assessment, country and regional comparison, relevant planning implications and, where appropriate, one or two constrained scenario views.
Claim boundary
COVARIS does not predict clinical outcomes, placebo response or treatment effect. It does not prove environmental causality, guarantee variance reduction, quantify ROI, reduce sample size, accelerate approval, certify ICH E17 compliance or perform PK/PD modelling.
COVARIS provides planning-stage decision support. It makes environmental context explicit, comparable and relevant to pre-protocol discussions about trial footprint, exposure adequacy, endpoint variability and study robustness.
In late phase 2 and phase 3 planning, this visibility can matter because geography, timing and study-design assumptions are costly to revisit once locked.
COVARIS supports sponsor-led planning discussions. It does not replace clinical, statistical, regulatory or operational judgement.
COVARIS helps sponsors and CROs screen planned trial countries, regions and enrollment windows for disease-relevant environmental instability before protocol lock.
COVARIS does not predict outcomes or prove causal effects. It provides planning-stage environmental context intelligence for sponsor-led clinical trial decisions.
COVARIS ApS
2100 Copenhagen
Denmark
+45 25 30 30 28
CVR-no.: 46484673