Data Management Strategies
Novo Compliance’s empowers our clients and the life sciences industry assistance architecting robust data management strategies that transform fragmented datasets (strained metadata, disparate clinical v. third-party DBs, incompatible data formats, mixing of synthetic v. real-world data, structured v. unstructured data, etc.) into harmonized, high-value assets. Novo Compliance’s approach integrates FAIR principles, regulatory alignment (e.g., GxP, GDPR, HIPAA), and scalable infrastructures providing and ensuring secure, interoperable, and audit-ready data environments across R&D, clinical trials, and post-market surveillance. By embedding semantic modeling, metadata governance, and real-time analytics, we empower organizations to unlock insights, accelerate decision-making, and maintain compliance in a rapidly evolving digital landscape.
Data Integrity
- ALCOA + (Complete, Consistent, Enduring & Available)
- Fit for Purpose Evidence
- Risk Based Proportionality
- End to End Traceability
- Hierarchy of accountability and responsibilities
Data Governance Processes
- Data Stewardship
- System Validation & Life Cycle Management
- Audit Trails and Unalterable Logging
- Data Lineage and Sources
- Data Transformations and Algorithm security
- Encryption, Integrity Checks and Cybersecurity
- Encryption, Integrity Checks and Cybersecurity
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