Custom Analyses: Elevating Aetion® Substantiate’s Capabilities for Tailored Research

At Aetion®, we recognize that biopharma, medtech, and other healthcare delivery organizations face increasingly complex questions that demand more than one-size-fits-all solutions. Modern research demands flexibility in study implementation, and researchers need tools engineered to navigate diverse challenges with rigor, agility, and speed. 

That’s why we introduced Custom Analyses, a feature integrated within Aetion® Substantiate, to enable research teams with programmers to code when needed while ensuring they can produce decision-grade evidence in a secure environment.

Guided Workflows Meet Flexibility: Custom Analyses Overview

Custom Analyses enables Substantiate users to use RStudio to design and execute their own analyses built on Substantiate-created analytic cohorts and variables, without compromising security or compliance. Researchers can store their Custom Analyses outputs in Substantiate for team collaboration and reproducibility. 

By integrating this developer environment into Substantiate’s protected ecosystem, users can confidently address complex questions and deliver actionable insights with flexibility, transparency, and compliance.

Key Features of Custom Analyses

• Access a Hosted RStudio Instance: Code in a secure, hosted RStudio environment without transferring sensitive data, ensuring compliance with strict data protection standards.

• Code Directly Atop Substantiate-created Cohorts: Leverage the Aetion API to transfer analytic cohorts into RStudio and access covariates created in Substantiate, streamlining workflows with pre-built datasets.

• Publish Results and Code Back to Substantiate: Store custom visualizations, tables, and outputs securely within Substantiate, ensuring findings are accessible and actionable for stakeholders. 

• Guarantee Reproducibility: Preserve and lock both code and original Analytic Cohort Files when results are published back to Substantiate, ensuring transparent, reproducible, and defensible research outputs.

By combining point-and-click software with robust coding options, Custom Analyses makes Substantiate the ideal solution for research teams tackling complex evidence-generation challenges.

Recently Released Feature Enhancements 

• Support for Multiple Cohorts: Analyze multiple cohort files in a unified workspace to streamline evaluations and uncover insights faster. For example, researchers conducting a vaccine safety study can integrate analytic cohorts for each dose into a single analysis. 

• HTML Publishing Command: Publish HTML files created in RStudio directly to Substantiate alongside JPG and PNG support. This enhancement offers programmers increased flexibility to create interactive, customizable outputs for tailored visualizations.

Planned Enhancements

• Access to Drug Pathway Analyses in Custom Analyses:  Researchers will soon be able to directly access time- and switch-based pathway data from Drug Pathway Explorations within Custom Analyses. This capability will streamline the evaluation of therapeutic strategies, offering greater efficiency for natural history studies and treatment landscape exploration.

Driving Results That Matter

Substantiate’s Custom Analyses equips researchers with the tools to address complex real-world evidence challenges by seamlessly integrating coding into Substantiate’s secure environment.

Key Benefits:

• Tailored Analyses: Enable researchers to implement any statistical method or analysis required for specific studies, leveraging the flexibility of custom coding.

• Enhanced Flexibility: Extend Substantiate’s capabilities with custom coding in RStudio, enabling adaptability for intricate analyses without compromising security.
• Collaborative Transparency: Securely store outputs such as visualizations and findings within Substantiate, enabling team access and tracking data provenance.
• Source File Integrity: Maintain guaranteed access to source files, ensuring transparency and alignment with regulatory needs for defensible results.
• Dynamic Communication: Share customized outputs like HTML reports and visualizations to effectively engage diverse stakeholders across regulatory, clinical, and commercial domains.

These key capabilities enable researchers to overcome barriers and produce high-quality evidence that informs critical decisions and advances patient care.

Redefine Evidence Generation With Substantiate

Aetion® Substantiate’s Custom Analyses reshapes the evidence generation landscape by combining no-code cohort-building workflows with code-based analytical processes in a secure, unified platform. Intuitive cohort-building capabilities integrate seamlessly with the flexibility of RStudio, enabling researchers to move effortlessly between structured workflows and custom coding. 

This integrated approach delivers rigor, efficiency, and adaptability. Research teams can tackle real-world evidence challenges with greater collaboration, reproducibility, and precision.

The result? Smarter insights. Faster decisions. Better outcomes.

Lead the way in evidence generation—Connect today to unlock the full potential of Substantiate.