ApoGI™

Next-Gen End to End Platform,
Automating your Clinical Study
Deliverables

ApoGI™ is an integrated, automation platform that leverages AI (Artificial Intelligence) and ML (Machine Learning) and puts focus on standards and metadata management to streamline processes and the generation of artifacts typically associated with the clinical study lifecycle. Ensuring process/artifact consistency, streamlining and automating repetitive tasks and artifact generation to allow subject matter experts to focus on science and deriving additional value/insights from clinical trial data.

Key Features

Life Science SMEs drive our custom application development services, supported by leading-edge technologists and software development experts seasoned in delivering solutions and services that resonate with our sponsors. Our technical teams support solutions development and services in the following areas:

  • Next generation enterprise platform
  • Ability to integrate and leverage data from multiple sources
  • Anonymization of data for sharing it internally or externally in real time
  • Leveraging new technologies to support artifact generation from protocol to CSR
  • Automated process workflows to facilitate Governance, Artifact Generation, Review / Approval / Sign-off
  • ApoGI has developed Data Visualization module to analyze information related to Clinical Metadata and Data and provide data insights in the form of visual elements like charts, graphs and maps to understand the trends, outliers and patterns in data.
  • Availability of Structured Governance Framework to track metadata at multiple hierarchical levels
  • Impact Analysis/Traceability Tool (across all levels)
  • Availability of Structured Governance Framework to track metadata at multiple hierarchical levels 
  • Impact Analysis/Traceability Tool (across all levels)
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STUDY DESIGN EXTRACTOR

  • Platform for Extracting Protocol Information like Trial Design Elements, Study level Information, Visit Assessment schedules along with Domains that need to be collected for the study from the Protocol Document.
  • Identify existing Metadata availability from MDR and identifying new Domains that would need to be created for the study for Data collection Elements

USP: Unmet needs in the Industry to automate extracting information from the Protocol Document to reduce Study Build timelines.

STUDY
BUILD

  • Managing Study level metadata, copying from Global.

  • Creating new metadata at study level from scratch for Data collection Elements

  • Change request by Study user for Global Metadata Governance

  • File system

USP: Meeting unmet Industry needs to manage all Study Level Metadata in one place from Data collection to Data reporting.

DATA TRANSFORMATION

  • Importing the raw datasets/non-clinical study data and their classification with tags
  • Providing the framework for source to target mapping with user interface screen
  • Providing the basic default functions for mapping datasets & supports custom mapping
  • Automap functionality to demonstrate current mapping techniques, supports manual mapping
  • Execution logs, method usability report and impact assessment, mapping coverage report and export
  • Exporting the transformed data and mapping spec generation and file system

USP: Data Transformation/Data conversions made easy by applying Automapping, Machine learning algorithms to reduce Submission Timelines.

TLF SHELL GENERATOR

  • Platform for facilitating the finalization of all the templates for generating Tables, Listings and Figures as part of setting up the expectations between the Statisticians and the Statistical Programmers.
  • Product supports to create TLF from scratch, allows to import existing TLF shells/catalog from existing library and generate metadata to be stored back in MDR.
  • Supports various formats in both Import and Export functionality.

USP: Product will be used to generate the   actual study artifacts: Tables, Listings and Figures using SDTM/AdAM dataset

ApoGI Product Suite

ApoGI Platform Modules

ApoGI platform consist of ADMIN and MDR

ADMIN

ADMIN module has the following functionality:

  • Configuration screen for Application Settings like Password Policy, Session Timeout, Disable Modules
  • Grouping tasks to the Workflow, creating users and assigning roles
  • Dashboard that can provide high level statistics of usage of different artifacts
  • Review the Audit module for DDL/DML Operations.
  • 21CFR Part 11 Compliance and Reporting

Controlled, authenticated environment to manage users at a single point for multiple applications

METADATA REPOSITORY (MDR)

METADATA REPOSITORY (MDR) module within the platform consist of:

  • Importing both Legacy/CDISC Metadata into ApoGI System with Autorecognition of CDISC standards.
  • Managing the Legacy/CDISC Metadata with any edits/updates to the domain/element.
  • Governance model to support Governance process and understanding the Impact assessment of studies using the impacted Domain/Data elements.
  • Exporting functionality available for metadata.
  • Intuitive Dashboard to reflect on the KPIs used in Standards
  • 21CFR Part 11 Compliance.

Addresses unmet Industry challenges to manage Metadata Repository on a single platform for all types of studies.

ApoGI Products

ApoGI Productcs consist of ADMIN and MDR

STUDY DESIGN EXTRACTOR
  • Platform for Extracting Protocol Information like Trial Design Elements, Study level Information, Visit Assessment schedules along with Domains that need to be collected for the study from the Protocol Document.
  • Identify existing Metadata availability from MDR and identifying new Domains that would need to be created for the study for Data collection Elements

Unmet needs in the Industry to automate extracting information from the Protocol Document to reduce Study Build timelines

STUDY BUILD
  • Managing Study level metadata, copying from Global.
  • Creating new metadata at study level from scratch for Data collection Elements
  • Change request by Study user for Global Metadata Governance
  • File system

Meeting unmet Industry needs to manage all Study Level Metadata in a single platform from Data collection to Data reporting.

DATA TRANSFORMATION​
  • Importing the raw datasets/non-clinical study data and their classification with tags
  • Providing the framework for source to target mapping with user interface screen
  • Providing the basic default functions for mapping datasets & supports custom mapping
  • Automap functionality to demonstrate current mapping techniques, supports manual mapping
  • Execution logs, method usability report and impact assessment, mapping coverage report and export
  • Exporting the transformed data and mapping spec generation and file system

Data Transformation/Data conversions made easy by applying Automapping, Machine learning algorithms to reduce Submission Timelines.

TLF SHELL GENERATOR​
  • Platform for facilitating the finalization of all the templates for generating Tables, Listings and Figures as part of setting up the expectations between the Statisticians and the Statistical Programmers.
  • Product supports to create TLF from scratch, allows to import existing TLF shells/catalog from existing library and generate metadata to be stored back in MDR.
  • Supports various formats in both Import and Export functionality.

Product will be used to generate the   actual study artifacts: Tables, Listings and Figures using SDTM/AdAM dataset.

Key Benefits

Looking to enhance your organization’s impact?

Our technology-empowered experts are available to assist you in the following areas:

  • ApoGI offers one stop platform-based solution which helps reduce multiple hops between systems and ensures data and document traceability

  • ApoGI is future ready with AI enabled Automation platform with “Innovation as Service” model for custom needs as required

  • Plug-n-Play modules in the ApoGI platform help manage industry requirements along with legacy products

  • Focus consequently enhances the value of the metadata and related transformations making it possible to extend the capabilities of the platform to cover additional artifacts, processes, and use cases.
Navigational Panel:
  • Study, Doc, Repository, Strategy Application, and tracking of strategies applied
  • Parameter-driven Risk Analysis and Data Utility per EMA guidance. Determine by data/variable or determine for entire study/project.
Strategy Application:
  • Repository and “Pre-De-ID Analysis” tools provide methods/strategies to the user to leverage with confidence speeding setup and delivery.
View Panels:
  • See datasets before/after and strategies applied immediately to confirm which provide the best results for a specific project. “Sync scroll” summary statistics and histograms are available to make it easier for reviewers/analysts to evaluate the effectiveness of applied de-identification strategies.

  • View docs before/after with “Redaction Proposal”-like display. De-identified values are highlighted and easily found for review by either the navi panel or via a drop-down menu directly over the doc. Annotations show how the value will appear in accordance with EMA Policy 0070 in the final de-identified doc.

  • Get results before/after with interactive visualizations to identify data risks over/under threshold(no comma) and alternate displays to view risk separately by quasi-identifiers/variable.

Strategy Types:
  • From basic “search-and-replace/redact” to ML and regular expressions to leveraging of de-identified datasets to queries and patient-specific/narrative strategies.