Enforcing Clinical Trial Compliance Through Blockchain

On September 23, a key milestone will be reached: Oshimed, the first solution that makes patient consent compliance unavoidable in clinical trials, will be officially unveiled during the BioWin Days.

A New Standard for Clinical Research

Every year, clinical studies face invalidation due to poor consent management, affecting nearly 10% of them. In fact, 40% of consents are still collected on paper, exposing trials to errors, loss of data, and non-compliance.

Oshimed transforms this critical weakness into a strategic advantage. It was developed through a consortium and co-funded by the DigitalWallonia4Trust program, therefore, Oshimed delivers a concrete, immediate solution based on four core pillars:

• Immutable Patient Consent:
  The blockchain ledger records every consent, re-consent, or withdrawal immutably. All changes are auditable and verifiable, ensuring regulatory compliance and building trust among patients and authorities.
• Patient Journey Tracking:
  Using a token-gating system, each step of the patient’s journey is certified and validated. Investigators and sponsors gain real-time visibility into patient progress through transparent, actionable insights.
• Multi-role Management:
  The platform supports complex clinical structures by offering differentiated access rights and customized workflows for all stakeholders—sponsors, CROs, investigators, ethics committees, and regulators.
• Multi-site Capabilities:
  Oshimed enables seamless management of multi-site trials by providing a unified view of patient data, progress, and compliance across all participating locations.
  

Additional Features:

• Built-in compliance with global standards such as GDPR, HIPAA, and CFR Part 11
• Enhanced patient control over how their sensitive data is used and shared

By combining blockchain with Decentralized Identity (DID), Oshimed establishes a robust trust framework between patients, investigators, sponsors, CROs, and ethics boards.

BE Blockchain: The Technology Architect

BE Blockchain is the technology provider behind Oshimed. Beyond the development of the application, we designed and deployed the blockchain protocol that enables consent notarization and immutability. Our API-first architecture ensures interoperability with existing clinical systems.

This strategic partnership illustrates our core mission: to leverage blockchain as a practical tool for compliance, transparency, and trust in medical research.

A Broader Vision: Towards a Universal Health Data Protocol

Patient consent is just the beginning. Oshimed aims to become a universal protocol for indexing and notarizing health data.

• Cloud-agnostic and deployable in any IT environment without dependency on a single infrastructure
  
• Will progressively integrate with EMRs (Electronic Medical Records) to connect hospitals, CROs, sponsors, and regulators
  
• Will include automated payment management for clinical trials (e.g., patient compensation, investigator fees, and site costs)
  

Ultimately, this roadmap positions Oshimed as a trusted infrastructure for global clinical research and digital health.

Where to Discover Oshimed?

📅 September 23, BioWin Days 2025, Namur
Join us at the BeCRO pavilion (Belgian CRO Association), where our team will deliver exclusive demos of Oshimed.

👉 Learn more and register: www.biowinday.org