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Mapper

Data mapping and standardization from any source without programming, using drag-and-drop transformation to SDTM and other clinical data standards.

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Overview

elluminate Mapper is a self-service, no-code/low-code data mapping and standardization application within the elluminate Clinical Data Cloud. Designed for clinical programming teams, data analysts, and non-programmers alike, Mapper enables users to rapidly unify data from diverse sources, perform complex transformations to SDTM and other standard formats, and publish curated datasets for analytics — all without writing custom or ad-hoc programs.

Mapper addresses the growing challenge of managing increasing volumes of external data sources in clinical research. By providing a fully compliant and auditable environment, it empowers organizations across biotech, pharma, and CROs to standardize clinical data efficiently, reduce reliance on SAS programmers or third parties, and deliver self-service access to data streams across the clinical enterprise.

Core Capabilities

  • Drag-and-drop interface that allows non-programmers to map and transform source data to required target formats without programming knowledge
  • Support for complex data transformations to SDTM and other industry- and company-specific clinical data standards
  • No-code/low-code design with the option to apply additional SQL code for more detailed customization and transformation
  • Ability to accept any incoming data structure and transform it to whatever format is required for reporting or analysis
  • Real-time data visualizations and reports delivered to clinical teams conducting data and safety review
  • Ensures compliance with industry- and company-specific clinical data standards within a fully auditable environment

Data Ingestion and Mapping Features

  • Maximum flexibility for ingesting data across numerous sources
  • Out-of-the-box automated integration with Medidata Clinical Cloud
  • Dynamic mapping templates that automatically map different types of data upon receipt, saving significant time
  • Enables data analysts to map directly to clinical data standards including SDTM, reducing cost and increasing control
  • Automatic triggering of mappings: the system monitors imported data and, unless opted out, triggers associated mappings at every import without manual intervention

Out-of-the-Box Transformation Functions

  • Renaming variables
  • Changing data types, field lengths, and field labels
  • Reordering columns
  • Pivot and unpivot operations
  • Creating derived variables and aggregate variables
  • Many additional frequently used data transformation functions included as standard

Workflow and Self-Service Access

  • Clinical programming teams and data analysts use Mapper to rapidly provide end users with self-service access to curated datasets and visualizations
  • Data is not required to flow through Mapper, but Mapper serves as the tool used to move data between data stores within the elluminate platform
  • Mapped domains and transformations can be automated to trigger on every data import, reducing manual effort
  • Supports production of compliant, submission-worthy SDTM datasets, as validated by excellent Pinnacle 21 scores in real-world use

Mapper is part of the broader elluminate Clinical Data Cloud platform, which integrates with products including Data Central, eIQ Review, and the Statistical Computing Environment. It operates within a fully compliant and auditable environment, making it suitable for regulated clinical trial data workflows and regulatory submissions.

Meta

Domain
Clinical & Regulatory Data Standards
Subdomain
CDISC & Clinical Data Standards Management
Software type(s)
Workflow Automation
Deployment type(s)
Cloud / SaaS
Industry vertical(s)
PharmaBiotechCRO
Development stage(s)
Clinical
Target user(s)
Bioinformatician / Computational ScientistQA / Regulatory AffairsIT / Systems Admin / Data Engineer
Compliance standard(s)
21 CFR Part 11ICH