Digital Protocol Platform & Lifecycle Management
Protocol deviations, inconsistent endpoints, and downstream data errors cost clinical sponsors millions and delay trial timelines. Manually keying the same trial design parameters across dozens of clinical systems creates compliance gaps before the study even launches.
GBC-DigiPro transforms protocol design into machine-readable CDISC USDM v4.0 data. From AI-assisted authoring to real-time ICH M11 CeSHarP compliance and instant legacy PDF extraction, DigiPro creates an auditable single source of clinical truth.
- CDISC USDM v4.0 standard-native architecture for every trial element
- 1-Click ICH M11 Check with real-time CeSHarP gap & blocker detection
- 50 Pages Per Minute legacy PDF-to-USDM AI conversion rate
- 10 Minute Drafts for downstream ICF, SAP, DMP, and TMF generation
- 40+ Pre-Built Connectors linking Veeva, Medidata, Oracle, and EHR feeds
- Protocol Studio with AI Design Guidance: Author structured objectives, eligibility criteria (SNOMED-coded), and complex Schedule of Activities (SoA) tables. Intelligent AI suggestions provide endpoint benchmarks pulled from hundreds of real-world clinical studies.
- Automated ICH M11 CeSHarP & Cross-Reference Validation: Run instant compliance reports pinpointing blocker-level gaps with one-click direct navigation to the target input field. The matrix validator automatically verifies that all cross-section links remain synchronized.
- AI Legacy Protocol Converter: Unlock 20 years of legacy study documents. Upload 200+ page protocol PDFs and convert them into clean CDISC USDM JSON at 50 pages per minute. AI scores extraction confidence per element, initiating human verification whenever confidence falls below threshold limits.
- Downstream Document Generation & ClinWrite Handoff: Finalize and e-sign once (21 CFR Part 11) to trigger automated downstream creation. Instantly draft ICFs, SAPs, Data Management Plans, and TMF indexes, transferring them straight to ClinWrite for regulatory review.
- Pre-Built Ecosystem Integrations: Connects via 40+ out-of-the-box connectors to Medidata Rave, Veeva Vault, Oracle Clinical One, Castor, REDCap, and ARGUS. Approve once, synchronize everywhere.
Legacy Protocol Workflows vs. GBC-DigiPro
| Protocol Lifecycle Capability | Legacy Word & PDF Workflows | GBC-DigiPro Platform |
|---|---|---|
| Data Architecture | Unstructured prose locked in PDFs | CDISC USDM v4.0 structured JSON schema |
| Compliance Verification | Manual review & post-hoc checklists | Real-time ICH M11 CeSHarP automated check |
| Downstream Artifacts | Re-keyed manually across 10+ clinical tools | First drafts generated in <10 min for ClinWrite review |
| Legacy Ingestion | Manual retyping taking weeks per study | AI conversion at 50 pages/minute with confidence gates |
| Data Integrity & Audit | Track changes and multiple disconnected drafts | 21 CFR Part 11 e-signatures & ALCOA++ audit trails |
Ready For Intelligent Protocol Automation?
GBC-DigiPro is more than a protocol drafting tool; it is an intelligent clinical architecture layer designed to stop trial deviations at the source. By uniting structured CDISC USDM authoring, real-time ICH M11 validation, and automatic downstream propagation, DigiPro delivers measurable impact: zero protocol-to-system translation errors, weeks saved per clinical startup, and complete GxP auditability across every study milestone.