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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

Agile clinical development

System integration

Migration and harmonization

End-user adoption

Service offering

Key results

Business outcomes

Process excellence

End-user adoption

Data migration to a unified standards management

Integration approach and methods

Group 47664

End-user adoption and training

Group 47590

Metadata repository implementation and integration

Group 47656

End-to-end validation and verification

Group 47623

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.