ApoGI

ApoGI™ is an integrated, end-to-end metadata management and automation platform developed by GENINVO, designed specifically for the life sciences industry. By leveraging Artificial Intelligence (AI) and Machine Learning (ML), ApoGI™ streamlines the generation and management of artifacts associated with the clinical study lifecycle — from protocol through to Clinical Study Report (CSR). The platform is built for pharmaceutical sponsors, clinical data managers, statisticians, and statistical programmers who need to reduce study build timelines, ensure process consistency, and free subject matter experts to focus on science and deriving deeper insights from clinical trial data.

ApoGI™ functions as a one-stop metadata solution platform, consolidating multiple processes and systems into a single environment. Its modular architecture — comprising ADMIN, Metadata Repository (MDR), Study Build, Data Transformation, and TLF Shell/Report Generator — enables organisations to manage all clinical metadata in one place, from data collection through to data reporting and regulatory submission.

Key Platform Features

• Next-generation enterprise platform built for the clinical study lifecycle
• Ability to integrate and leverage data from multiple sources
• Real-time anonymisation of data for internal or external sharing
• Leverages new technologies to support artifact generation from protocol to CSR
• Automated process workflows to facilitate governance, artifact generation, and review, approval, and sign-off processes
• Data Visualisation module to analyse clinical metadata and study data, presenting insights through charts, graphs, and maps to identify trends, outliers, and patterns
• Structured Governance Framework to track metadata at multiple hierarchical levels
• Impact Analysis and Traceability Tool spanning all levels of the platform

Study Design Extractor

• Extracts protocol information including trial design elements, study-level information, and visit assessment schedules directly from the Protocol Document
• Identifies domains required for data collection within the study
• Identifies existing metadata availability from the MDR and flags new domains that need to be created for the study
• Addresses the unmet industry need to automate protocol extraction and reduce study build timelines

Study Build Module

• Manages study-level metadata, including copying from global metadata repositories
• Supports creation of new metadata at the study level from scratch for data collection elements
• Enables change requests by study users for global metadata governance
• Includes an integrated file system for study asset management
• Meets the unmet industry need to manage all study-level metadata in one place, from data collection to data reporting

Data Transformation Module

• Imports raw datasets and non-clinical study data with classification and tagging capabilities
• Provides a framework for source-to-target mapping via a dedicated user interface
• Includes default mapping functions for datasets and supports custom mapping configurations
• Automap functionality demonstrates current mapping techniques and supports manual mapping where required
• Generates execution logs, method usability reports, impact assessments, and mapping coverage reports with export capability
• Exports transformed data and generates mapping specifications with file system integration
• Applies automapping and machine learning algorithms to reduce submission timelines

TLF Shell Generator

• Facilitates the finalisation of all templates for generating Tables, Listings, and Figures (TLF), aligning expectations between statisticians and statistical programmers
• Supports creation of TLF shells from scratch, as well as import of existing TLF shells or catalogues from existing libraries
• Generates metadata to be stored back in the MDR for reuse and governance
• Supports various formats in both import and export functionality
• Generates actual study artifacts — Tables, Listings, and Figures — using SDTM and ADaM datasets

Key Benefits

• One-stop platform-based solution that reduces multiple hops between systems and ensures data and document traceability
• Future-ready AI-enabled automation platform with an "Innovation as a Service" model to accommodate custom organisational needs
• Plug-and-play modules that manage current industry requirements while remaining compatible with legacy products
• Enhances the value of metadata and related transformations, enabling the platform to be extended to cover additional artifacts, processes, and use cases over time

ApoGI™ is developed by GENINVO, with custom application development driven by Life Sciences subject matter experts supported by leading-edge technologists and software development professionals. The platform is designed to integrate with existing enterprise environments and is positioned to scale alongside evolving regulatory and operational requirements in clinical development.