Digital Data Flow (DDF) Accelerator

Clinical studies lose time after protocol approval because the same information is repeatedly interpreted and re-entered across EDC, CTMS, IWRS, data management, monitoring, and documentation workflows. This creates avoidable delay, inconsistent definitions, and traceability gaps.

The industry is already moving from document-centric protocols toward structured study definitions. TransCelerate’s Digital Data Flow initiative advances protocol digitalization, CDISC USDM provides a standard model for exchanging study-definition information, and ICH M11 establishes a harmonized protocol structure. The opportunity is not only to prepare for that shift, but to improve study start-up now.

Hexaware’s Digital Data Flow Accelerator converts protocol content into a governed CDISC USDM 4.0 study definition. After validation and approval, the record can be published through an SDR Hub and made available to existing systems and document workflows through APIs or governed exports. This supports downstream activities such as EDC and CTMS setup, IWRS workflows, data management plans, central monitoring plans, and other study assets without forcing a wholesale platform replacement.

Traceability is central to the approach. Extracted study elements and review answers link to the supporting protocol page or section, allowing teams to verify evidence before approval. Automation accelerates extraction and drafting, while validation, governance, and human review keep the approved record controlled.

Inside this flyer:

• Why the move toward USDM and structured protocols makes early action valuable
• How repeated protocol interpretation delays downstream execution
• How the SDR Hub distributes approved study information across systems and documents
• How source-linked traceability supports review, confidence, and control
• How Hexaware can demonstrate the approach using one representative protocol

Learn how Hexaware Digital Data Flow Accelerator  enable clinical development while improving quality, compliance, and operational efficiency.