Fit For Purpose Assessment

The Fit For Purpose Assessment by Cornerstone AI is a generative AI-powered platform designed to rapidly and comprehensively characterize real world data (RWD) for life sciences research. It is built for biopharma sponsors, data officers, and research teams who need to evaluate clinical data quality at scale — reducing assessment timelines from many weeks to just hours while delivering deeper, more objective insights than traditional approaches.

At the core of the platform is a multi-step generative AI algorithm that maps, harmonizes, transforms, validates, and error-detects clinical data across formats and sources. The system is self-learning and indication-agnostic, having been applied across a wide range of disease areas including Oncology, Rheumatoid Arthritis, Alzheimer's Disease, COVID, Infertility, and more — as well as data from patient registries and Phase II, III, and IV clinical trials, covering datasets ranging from fewer than 100 patients to over 100,000.

How the Algorithm Works

1. Connect and learn: Cornerstone AI maps and harmonizes clinical data, making it analysis-ready across diverse formats and sources.
2. Transform the data: The platform processes and validates data to enable precise modeling and assessments.
3. Model and detect errors: The AI detects and explains data errors, generating comprehensive quality metrics with interpretable reasons for each identified anomaly.

Product Features

• Data Quality Assessment Browser: Provides quality metrics at the dataset, table, patient, and field level, and summarizes patient counts across all data attributes.
• Cohort Builder: Accurately identifies patients meeting inclusion and exclusion criteria at scale, leveraging the full Cornerstone AI algorithm including ontology mapping, data transformation, and quality metric generation.

Types of Errors and Anomalies Detected

• Date sequencing errors and dates too far in the past
• Clinical inconsistencies across records or tables
• Biologically implausible values
• Value misplacements
• Unstandardized or mis-standardized text fields
• Tokenization errors
• Clinically duplicate records

Key Benefits

• Achieve consistent, reliable quality checks within and across datasets
• Speed up data assessments from many weeks to hours
• Comprehensive characterization enables smarter, more objective decision-making
• Approximately 5x more affordable than traditional billable vendor solutions on an annual basis
• Dynamic, queryable quality reports replace static Excel outputs

Amplifying RWD Maturity

• Confirm data purchases: Applicable to new and existing data acquisitions, enabling users to quickly filter for key attributes of clinical interest — for example, oncology gene mutation data.
• Become a leader in RWD quality: Build a library of data assets with objective, timely quality ratings and dynamic reporting capabilities.
• Unified quality framework: A point-and-click interface accessible to both technical and non-technical users, enabling teams to achieve more with less technical manpower and provide targeted feedback to data sources to improve underlying data quality.

Cornerstone AI also provides expert support in translating detected errors into actionable pipeline fixes, helping both data providers and biopharma customers who have licensed data. The platform can identify issues stemming from incorrectly merged source tables, incomplete JSON parsing, or incorrect NLP of unstructured clinical notes, making it a comprehensive solution for organizations seeking to elevate their real world data quality standards.