WHAT WE DO
Translational Bridging
The work that gets a program from where it is to where it needs to be — through first-in-human readiness, regulatory review, and the evidence sponsors need to negotiate access. Our translational team builds that evidence with the populations the standard databases don't cover.
BRIDGE BLUEPRINT
Two Translational Modes, One Evidence Engine
Most translational work falls into two patterns.
Early translational means getting from preclinical signal to first-in-human — feasibility, biomarker strategy, and the evidence package that supports an IND.
Late translational means everything that happens after a candidate works — generating the safety, effectiveness, and real-world data that regulators, payers, and clinicians need to act on the program.
Rubix LS runs both, and we organize this page that way so you can find the work that matches where your program is right now.
FROM SIGNAL TO FEASIBILITY
Early Translational
Before a candidate enters its first clinical trial, the questions are sharp, and the answers are expensive to get wrong.
Is the signal real? Is the population identifiable? Will the endpoint translate? Is the dose defensible?
Our early translational team works with sponsors and investigators on feasibility assessments, biomarker validation, endpoint selection, and the integrated evidence plans that make an IND submission readable to a reviewer instead of defensible after one.
FROM APPROVAL TO REAL-WORLD APPLICATION
Late Translational
Once a candidate works, the question changes.
Sponsors now need to show regulators that safety holds up over time, show payers that real-world effectiveness matches the trial results, and show clinicians that the populations who actually have the disease look like those in the label.
Our late translational team builds the post-approval evidence stack — Phase IV studies, registry programs, real-world data analyses, and the population-specific outcomes work that turns an approval into adoption.
EVIDENCE-TO-VALUE STACK
Evidence for the Audiences Your Program Has to Convince
HEOR (Health Economics and Outcomes Research)
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Outcomes measurement strategy and value evidence planning
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Comparative effectiveness framing and patient-reported outcomes
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Health resource utilization insights to support decision points
Health Economics and Reimbursement
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Payer-relevant evidence strategy aligned to real-world decision makers
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Coverage and reimbursement considerations integrated into evidence design
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Value story development grounded in measurable outcomes
SDoH and Equity Analytics
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Barrier identification and segmentation to reflect real populations
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Community engagement approaches and equity endpoints
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Outcome reporting that shows who benefits and where gaps persist
Costing and Affordability Models
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Budget impact and cost-effectiveness models to support access and uptake
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Patient affordability models with transparent assumptions and populations
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Evidence designed for the end in mind: patients, providers, payers, regulators, and communities
Cross-Cutting Capabilities
A few things show up in every translational program we run, regardless of phase or therapeutic area:
Capability list:
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Population characterization across the 25M+ patient dataset — including geographies, demographics, and disease presentations standard clinical databases miss
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Regulatory strategy and submission support — from pre-IND consultations through label negotiation
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Real-world data integration — claims, EHR, registry, and patient-reported data sources
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Biostatistics and study design — for trials, registries, and observational studies
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Health economics and outcomes research — payer-relevant evidence built from program-relevant data
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Federal contracting capabilities — for translational work funded or co-funded through HHS, CDC, DoD, NIH, and other federal partners
Real-World Studies & Trials
Explore ongoing Rubix LS studies to see our commitment to transparency, active research leadership, and closing real-world evidence gaps.
DEVELOPMENT STAGE
Project Panacea
Breast Cancer
Project ARCHNGL
​Neurodegeneration
Project Aegis
Autoimmune Disorders
Contract Research Organization
Rubix LS delivers full-spectrum CRO services designed to accelerate clinical development with precision and flexibility. Our teams integrate regulatory expertise, real-world data, and inclusive trial design to drive faster, more impactful research outcomes.
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Federal Projects
Rubix LS is a trusted partner for federal agencies seeking agile, responsive contract research solutions. We bring cross-disciplinary teams and life sciences innovation to the front lines of federally funded public health projects.
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Evidence That Holds Up to Regulators, Payers, and Providers
Across early and late translational work, our teams build the evidence stack your program needs at every decision point — from first-in-human readiness to post-approval adoption. Tell us where the gaps are.