Oshimed – Patient Consent Traceability in Clinical Trials

Context

Clinical trials are becoming increasingly complex, with more sites, protocols, and requirements from health authorities. At the same time, pressure is growing on data integrity, cybersecurity, and the ability to prove, at any point in time, that every step is compliant.

In this context, laboratories and CROs must balance operational efficiency, strict regulatory compliance, and enhanced patient data protection throughout the entire study lifecycle. To put this into perspective, 85% of clinical trials face delays, and a single week of delay after approval can represent up to $24 million in lost value for a sponsor.

Industry Challenges

• Consent as a major source of regulatory issues: Problems related to consent (wrong versions, missing signatures, poorly managed updates) remain one of the most frequent causes of deviations identified during inspections. It is estimated that up to 10% of studies may be compromised by insufficient consent tracking.
• Fragmented consent data: Consent information is spread across different systems and stakeholders, making controls and audits longer and riskier for studies.
• Difficult to gather compliance evidence: It is often complex to quickly reconstruct who consented, to what, and when, on the correct version of the document.
• Increasing regulatory pressure: Expectations around traceability, data protection, and compliance with regulatory frameworks (such as GDPR or the European regulation EU CTR 536/2014) grow with every new study.
• Patient trust to be strengthened: Patients need greater transparency about how their data is used in order to agree to participate and remain engaged in clinical trials.

Solution

Oshimed offers a patient-centric consent management platform designed to eliminate data fragmentation and secure processes for CROs and biotechs.

• Traceable and immutable records: Every consent is recorded in a traceable and immutable way, with a precise timestamp that makes it possible to know exactly when a patient consented to which document.
• Compliance evidence available at all times: The platform provides ready-to-use compliance proofs, facilitating inspections and reducing regulatory risk exposure for clinical studies.
• Step-by-step patient journey control: Oshimed links consent to the patient journey, ensuring that certain steps — such as randomization or investigational product dispensing — can only proceed once all consent conditions have been met.
• Operational efficiency for study teams: By making consent data more reliable and immediately usable, the solution simplifies the work of study teams and reduces the time spent reconstructing consent histories.
• Privacy by design and data protection: Oshimed applies a privacy by design approach, with pseudonymized patient data and clear access governance, to meet GDPR requirements and health authority standards.

Key Benefits & Impacts

• Fewer deviations identified during inspections: Clear consent traceability reduces irregularities and makes inspections faster and less stressful.
• Reduced regulatory risk: Having directly accessible compliance evidence decreases regulatory exposure and the risk of study delays due to non-compliance.
• Simplified monitoring process: By making the right consent information easier to access, Oshimed reduces the time spent verifying and reconstructing data for study follow-up.
• Easier site adoption: A workflow aligned with on-the-ground realities simplifies the work of site staff and encourages adoption of the solution.
• Competitive advantage for CROs and sponsors: Stakeholders who can demonstrate built-in traceability and auditability stand out with authorities, partners, and clients.
• Strengthened patient trust: Greater transparency on data usage and enhanced protection contribute to building patient confidence and engagement in clinical trials.

Conclusion

Oshimed positions itself as a patient consent management platform that combines blockchain, traceability, and regulatory compliance to secure clinical studies end to end.

By delivering reliable and transparent consent proof, the solution helps CROs, sponsors, and sites collaborate around better-protected and more easily controlled patient data.

“With Oshimed, we finally have immediate and reliable audit proof on consent, which has profoundly simplified the work of the CRO.” — Ingrid Van Rompaey, CSO & Co-founder, Oshimed

 Learn more at oshimed.com or contact us to explore how Oshimed can secure patient consent traceability in your clinical studies. Contact-us