Skip to content
Main-Banner

Real-world Data (RWD) and Real-world Evidence (RWE)

Accelerate clinical, regulatory, and market access decisions by using agentic AI to unify diverse data and elevate actionable evidence.

Service-Overview-1

Service Overview

Regulatory agencies increasingly expect real-world evidence to complement or replace traditional trial data. Yet translating the volume, velocity, and variability of RWD into submission-ready analysis remains a persistent challenge.

ClairLabs deploys AI-augmented pipelines to harmonize EHR records, claims data, registries, genomic datasets, and wearable outputs into actionable, audit-ready evidence. Whether supporting an observational study, comparative effectiveness program, or payer submission, we structure every engagement around the evidence question that drives your program forward.

Infographic showing 96% variant ranking accuracy and 500K samples validated

The Impact We Make  

50% 

Faster evidence generation cycles

10B+

Patient records analyzed annually

40+

Regulatory submissions supported

100%

HIPAA & GDPR-compliant delivery

36%

Time reduction to generate evidence

Our RWD & RWE Offerings

From data sourcing and curation through advanced analytics and evidence synthesis, we cover the full real-world evidence lifecycle—built for scientific rigor and regulatory acceptance.
RWD-Strategy-&-Study-Design
TOUCH

We translate your evidence question into a scientifically defensible study design—selecting the right data sources,endpoints, populations, and comparators before a single record is pulled.

RWD Strategy & Study Design
Multi-source-Data-Acquisition-&-Curation
TOUCH

We source and harmonize EHR data, insurance claims, patient registries,genomic databases, wearable outputs, and PRO instruments, thus delivering clean, linked datasets ready for analysis.

Multi-source Data Acquisition & Curation
Observational-&-Comparative-Effectiveness-Studies
TOUCH

We design and execute observational studies and CER programs that generate causal, publication-quality evidence, while controlling for confounding using propensity scoring, instrumental variables, and causal inference frameworks.

Observational & Comparative Effectiveness Studies
HEOR-&-Burden-of-Disease-Analysis
TOUCH

We quantify disease burden, treatment costs, and quality-of-life impact across patient populations, producing the HEOR models that underpin payer submissions and value dossiers.

HEOR & Burden-of-Disease Analysis
Systematic-Reviews-and-Evidence-Synthesis
TOUCH

Our evidence synthesis teams conduct systematic literature reviews, meta-analyses, and network meta-analyses, consolidating the evidence base that supports regulatory filings and HTA submissions.

Systematic Reviews and Evidence Synthesis
Safety-Surveillance-and-Pharmacovigilance
TOUCH

We deploy AI-powered signal detection and longitudinal safety monitoring across RWD sources, identifying adverse events, drug interactions, and risk patterns that clinical trials cannot capture at scale.

Safety Surveillance and Pharmacovigilance
Patient-Journey-&-Epidemiology-Analytics
TOUCH

We map treatment pathways, care gaps, and unmet needs across geographies and demographics – generating the epidemiological intelligence that guides portfolio decisions and label expansions.

Patient Journey & Epidemiology Analytics
Regulatory-&-HTA-Evidence-Packages
TOUCH

We architect and deliver submission-ready evidence dossiers for FDA, EMA, NICE, and other regulatory and HTA bodies – ensuring every analysis meets the evidentiary bar for label claims and reimbursement decisions.

Regulatory & HTA Evidence Packages
AI-ML-powered-Evidence-Intelligence
TOUCH

Predictive models for disease progression, treatment response, and outcome stratification transform raw RWD into forward-looking intelligence, enabling smarter trial design, indication expansion, and risk management.

AI/ML-powered Evidence Intelligence
Market-Access
TOUCH

Understanding HCP segmentation, HCP behaviour, target market identification, and competitive analysis.

Market Access

Why ClairLabs

Speed Up
Speed Up

Evidence packages generated in weeks, not quarters—powered by automated data pipelines and AI-assisted analytics that compress every step of the study cycle.

Insight-led
Insight-led

Our integrated data hubs unify therapy-area and market-specific data into a single source of truth, helping teams deliver stakeholder-specific dashboards. These transform complex datasets into localized, decision-ready intelligence for clinical, regulatory, and commercial teams.

Risk Down
Risk Down

Privacy-by-design architecture, HIPAA- and GDPR-compliant workflows, and federated analytics frameworks that protect data integrity at every stage.

Impact Up
Impact Up

Evidence that drives regulatory label extensions, strengthens payer negotiations, and informs commercial strategy, creating value across the full product lifecycle.

Related Solutions

TOUCH
AI-GenAI Solutions AI/Gen AI Solutions
AI/Gen AI Solutions

Deploy custom GenAI models that decode biological data, automate evidence workflows, and surface trial insights—accelerating R&D decisions across your entire drug development pipeline.

Explore More
arrow

TOUCH
Multi-omics Intelligence & Management Multi-omics Intelligence & Management
Multi-omics Intelligence & Management

Integrate genomics, proteomics, and metabolomics through AI to surface multimodal biomarkers that sharpen translational research, precision diagnostics, and evidence generation for drug development programs.

Explore More
arrow

TOUCH
Bioinformatics Bioinformatics
Bioinformatics

Embed model-driven variant interpretation into validated NGS pipelines—enabling automated clinical reporting, ACMG-aligned variant ranking, and auditable insights for regulated diagnostics and RWE submissions.

Explore More
arrow

Related Posts

Contact-us

 

Begin Your RWE-powered Journey

Connect with our evidence experts to explore how ClairLabs can turn your real-world data into a competitive scientific and commercial asset.