Datalution

Datalution™ is a synthetic data generation solution developed by GENINVO, designed specifically for clinical trials and healthcare research. It enables clinical data management teams, biostatisticians, statistical programmers, and data scientists to generate meaningful, realistic synthetic patient data for testing and validation purposes — without waiting for real trial data to accumulate.

The platform addresses a critical challenge in clinical trial operations: the need for high-quality test data to validate electronic data capture (EDC) screens, edit checks, CDISC (SDTM) dataset generation programs, data visualizations, and Tables, Figures, and Listings (TFL) generation programs. Datalution replaces time-consuming manual data entry with automated, statistically representative synthetic datasets, supporting robust user acceptance testing (UAT) and downstream programming activities across the full biometrics delivery pipeline.

Core Capabilities

• Generates customizable synthetic datasets tailored to specific testing requirements for database, programming, and statistical setup activities
• Supports multiple data types including numeric, text (using expected categorical values or realistically appropriate free-text values), and date/time data
• Produces statistically representative data that accurately reflects real-world clinical trial patient behavior — the "Patient Journey"
• Enables testing of edge cases and unusual scenarios that may be difficult or impossible to replicate with real-world data
• Allows users to introduce statistical outliers into fields to stress-test edit checks and quality control processes
• Helps identify and resolve potential issues in delivery programs before real clinical trial data begins flowing in, minimizing delays to analysis and data review

Meaningful Data Generation Features

• Categorical variables are generated with values that comply with their associated code lists
• Continuous variables are generated within clinically appropriate normal ranges
• Outliers and intentionally bad values can be optionally introduced to validate range and list checks
• Date and time values are set in chronological order in compliance with the protocol's visit schedule
• Supports configuration to ensure a specific number of patients within defined treatment and demographic groups

Patient Journey Representation

• Configurable test data groups to simulate screen failures, completed patients, ongoing patients, and early withdrawal or discontinued patients
• Data form completion is generated in compliance with the characteristics of each patient group, ensuring realistic and clinically coherent datasets

Clinical Study Document Integration

• Leverages the Clinical Trial Protocol to inform data generation logic
• Incorporates EDC/CDMS specifications, including Medidata Rave's Annotated Layout Specification (ALS)
• Uses eCRF Completion Guidelines to ensure generated data aligns with study-specific data collection expectations

Datalution is built to support the full range of clinical data management and biometrics activities — including clinical data analytics, data science, and biostatistics — enabling teams to validate their systems and processes cost-effectively and at scale before production deployment on live clinical trial data.