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
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