Clinical standards management from protocol design to regulatory submission

    Creating organizational standards that adhere to industry standards to make the clinical development life cycle significantly streamlined, resulting in faster outcomes.

    Standards and metadata management solutions enabling speed to market


    Life sciences companies are rapidly adopting the Clinical Data Interchange Standards Consortium’s (CDISC) data standards for the clinical research process, standardizing content from planning and data collection to data analysis and reporting. To effectively manage organizational standards and enable correct information exchange and interpretation (interoperability), companies are also paying attention to data about the data, or ‘metadata’. Standards and metadata used throughout the clinical development life cycle are being managed in a centralized repository to facilitate their automated reuse.

    Successfully harness disparate data sources and software applications for intelligent application of data! Improve productivity, decision-making, and research efficiency by:

    • adopting CDISC standards management (from protocol design to regulatory submission)
    • enabling trial optimization resulting in faster outcomes
    • providing automated and consistent mapping with data lineage

    Clinical standards management

    Service offering

    Key results

    Business outcomes

    • Process excellence
    • End-user adoption
    • Data migration to a unified standards management
    • Integration approach and methods

    End-user adoption and training


    Metadata repository implementation and integration


    End-to-end validation and verification


    Compliant with FDA's soft mandate by end of 2023

    Agile clinical development

    • Real-time access to all study data through controls to ensure the utmost protection of participant safety and data integrity.
    • Streamline filing and submission of information to regulatory bodies.

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