Are You Ready for PDUFA V?

“Standardizing study data therefore involves standardizing the data, metadata, and the representation of relationships.”

Source: Appendix Data Standards and Interoperable Data Exchange, page 12, line 423,

d-Wise is ready to help you execute that strategy so when PDUFA V requirements take effect, you'll be ready to go.

Clinical Solutions

Readiness requires pulling together multiple initiatives into an executable strategy.

d-Wise is a recognized leader in establishing, implementing and efficiently leveraging CDISC data standards within a wide variety of clinical environments.

d-Wise provides a variety of services covering the many initiatives companies face to achieve readiness for these requirements:

  • Technology environment review, readiness assessments, plan recommendation, implementation and training
  • Creation of standards-compliant data and metadata repositories
  • Data integration to support work flow
  • Process optimization for enterprise-wide rollout and adoption
  • Standards governance programs

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