Clinical and statistical fraud, data tampering, and loss of audit trails are increasing concerns in global trials. We address this with immutable digital ledgers.
Securely hash and timestamp datasets, reports, and analysis outputs to ensure data immutability and traceability throughout the clinical lifecycle.
Use smart contracts to automate permissions, enforce version control, and validate protocol compliance across stakeholders.
Generate tamper-proof logs that record every change in datasets, code, and submission documents, ensuring total transparency for regulators and sponsors.
Integrate blockchain with eTMF, EDC, and submission systems to provide shared access and real-time visibility across CROs, regulators, and internal QA teams.
Certify data integrity at every critical milestone (e.g., lock, export, submit) using blockchain-based digital signatures.
Design privacy-preserving blockchain implementations compliant with GDPR, HIPAA, and other data protection frameworks.
Blockchain built on Hyperledger or Ethereum-compatible architecture. GDPR-compliant.
Protects IP, strengthens audit preparedness, increases regulatory trust, and future-proofs data integrity.