Enterprise RWE Platform

Powering the
Next Generation
Real-World Evidence

avidence® - The enterprise RWE platform that ingests, harmonizes, and analyzes complex real-world data using global regulatory standards — helping life sciences organizations generate trusted, submission-ready evidence faster than ever before.

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Observational Data Model Clinical Data Standards and Model AI/ML Powered and Driven GxP compliant
avidence® Platform
2.4M
Records
98%
Mapped
3x
Faster
Data Harmonization 92%
FDA Ready
Submission Validated
AI Powered
3x Faster Processing
PRODUCT OVERVIEW

Transforming Fragmented Data into Regulatory Evidence

Healthcare organizations struggle with fragmented real-world data, inconsistent standards, and limited traceability — slowing evidence generation and regulatory decision-making.

avidence® addresses this by providing a unified platform that connects ingestion, standardization, analytics, and submission readiness within a single auditable environment.

Built for pharma, biotech, CROs, and research teams, avidence® transforms siloed processes into a collaborative enterprise workflow that supports the complete real-world data lifecycle — from raw ingestion to regulatory evidence.

The platform supports multi-standard interoperability including Observational Data Models, Clinical Data Models, and the vocabularies and dictionaries used in healthcare and clinical data, while remaining technology-agnostic across cloud infrastructures.

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Multi-Standard Interoperability

OMOP, CDISC, FHIR, and custom models

Technology Agnostic

Multi-cloud and sponsor environments

GxP Compliant

21 CFR Part 11, GDPR, HIPAA ready

Journey of Data to Decisions

From Raw Data to Regulatory Evidence

1

Ingestion

Connect diverse real-world data sources including EHR, claims, registries, wearables, safety databases, and observational datasets.

EHR/EMR Claims Wearables
2

Harmonization & Transformation

Standardize and curate data using various healthcare and clinical data models and their associated vocabularies.

3

Data Analytics

Build cohorts, perform statistical analysis, assess bias, and generate evidence outputs.

Cohorts Statistics Bias Assessment
4

Evidence generation & Submission Readiness

Deliver traceable, provenance-driven, submission-ready datasets and documentation.

Audit Trails Validation
5

Continuous Intelligence

AI modules monitor mappings, automate scripts, and support decision workflows.

AI Monitoring Automation ML Models

Key Features & Highlights

Enterprise-grade capabilities for RWE generation

Unified RWE Platform

Execute ingestion, transformation, analytics, and evidence generation within one system.

AI-Driven Standardization

Mapping suggestions, terminology alignment, and automated code generation.

Sensitivity & Bias Tracking

Evaluate assumptions, document imputation rules, and maintain transparency.

Cohort Intelligence

Population selection for external control arms, label expansion, and HEOR.

Regulatory-Ready Architecture

Audit trails, provenance tracking, Study Data Reviewer Guide documentation, validation utilities.

Technology Agnostic

Supports multiple software applications and technologies, multi-cloud and sponsor environments.

Benefits / Value Addition / Problem Solving

Solves Fragmented Data Ecosystems

Unifies disconnected datasets into a single interoperable framework.

Prevents Data Loss

Captures clinically relevant free-text insights and preserves raw values.

Improves Evidence Quality

Provides structured analytics, bias visibility, and reproducible workflows.

Accelerates Time to Submission

Automates transformation from real-world data to Clinical data standards.

Enables Regulatory Confidence

Transparent documentation and traceability across the lifecycle.

Scales Across Organizations

Deploy from project-level licensing to enterprise rollout.

Impact Metrics*

0%

Reduction in manual mapping effort with AI-assisted ConceptX Mapper

0×

Faster time-to-evidence vs. traditional manual ETL pipelines

0%

Free-text data loss with the NLP-powered extraction module

100%

Auditability — every transformation decision logged and traceable

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Use Cases

Trusted across the pharmaceutical lifecycle

Clinical Trial Augmentation

Integrate EHR, registry, and claims data to strengthen study insights.

External Control Arms

Build accurate cohorts for comparative effectiveness studies.

Rare Disease Evidence Generation

Transform registry data into standardized datasets for phenotype analysis.

Post-Marketing Surveillance

Safety signal detection, drug comparisons, outcome monitoring.

HEOR & Market Access

Cost assessment, treatment patterns, population estimation.

Label Expansion & New Indications

Identify target populations across geographies.

Implementation Options

Flexible deployment models for every organizational need

Time-Bound Licensing

Best For: Project-based or trial use

Flexible subscription licensing for a defined project period. Ideal for pilot programs, single-study deployments, regulatory submissions with fixed timelines, or proof-of-concept evaluations before broader commitment.

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Most Popular Option

Custom Build

Best For: Study-specific or program-level engagement

Tailored implementation designed around your specific data environment, workflows, therapeutic area, and regulatory context. Fixed-cost delivery with defined milestones, dedicated SME support throughout, and clear deliverables at each stage.

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Enterprise Deployment

Best For: Enterprise-scale, multi-program or organization-wide deployment

Organization-wide rollout with full integration support, compliance documentation, multi-team user training, and ongoing maintenance. The complete avidence® experience — scaled to transform your entire real-world evidence operation.

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Start Generating Evidence Faster

Whether you are designing external control arms, preparing regulatory submissions, or scaling RWE programs — avidence® provides the infrastructure to move from data to decisions with confidence.

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