Case Study – R&D Clinical Operations
Problem: Legacy CTMS technology, ill-suited for modern clinical trials, lacked real-time insights and integration capabilities. The existing eTMF system, not inspection-ready, missed crucial features. This forced teams to rely on inefficient spreadsheets and emails for clinical trial tracking, leading to data redundancy and reduced visibility
Highlights
Shifted to a unified clinical system
Enhanced eTMF and CTMS security
Streamlined TMF workflows
Delivered real-time trial insights
Problem Statement
Organizations grapple with managing quality processes due to legacy tech barriers. Dispersed quality data, content, and training tools challenge data accuracy. Extended integration issues and recurring quality events impact efficiency. The demand: integrated, automated quality management solutions with custom tracking modules
Oxygen Minds Solution- Transformation towards Unified Clinical Vault Operations
Streamlined Clinical Vault Operations with Veeva
Vault eTMF Upgrade:
- Replaced the legacy eTMF system with the next-generation Veeva Vault eTMF.
- Migrated TMF documents from all stages: ongoing, closed, and archived.
- Established CTMS-to-eTMF integration for study data and monitoring visit report TMFs.
- Facilitated eTMF data transfer to submission applications.
- Decommissioned the outdated eTMF system.
Vault CTMS Transformation:
- Transitioned from the old CTMS system to Veeva Vault, consolidating clinical trial data management.
- Migrated complex legacy clinical trial data to the Veeva Vault.
- Developed numerous inbound/outbound integrations for clinical trial data.
- Decommissioned the old CTMS system.
Vault Study Startup Enhancement:
- Established study startup capabilities, accelerating site activation.
- Integrated country-specific intelligence into study startup workflows.
Tech-stacks Used
- Veeva Vault
- SnapLogic
- Globalscape
- MuleSoft
Implementation
- Customized security settings for varied user types.
- Automated milestone and document list creation.
- Unified data archival with enhanced security.
- Tailored CTMS functional enhancements.
- Risk-based study management.
- CTMS configurations for Japanese clinical trials.
- Integrated checklists for in-system approvals.
- Enhanced “Quality Issue” tracking in eTMF.
- Streamlined TMF document workflows.
- Adoption of TMF BOT and mobile apps.
- Simplified TMF data transfer process.
- Custom development using Veeva Vault’s SDK.
Benefits
Achieved a consolidated system enhancing clinical trial data management, trial master files, and study startup capabilities. This streamlined solution not only improved user experience but also boosted efficiency throughout the clinical trial workflow, accelerating trial execution and providing immediate insights.