Decentralized Post-Market Surveillance Hub

Manual, siloed safety data collection and reconciliation is a major operational drain. A decentralized hub automates data ingestion from manufacturers, healthcare providers, and clinical trials into an immutable ledger. This enables:

• Automated report generation for regulators like the FDA and EMA, cutting submission preparation time by up to 70%.
• Elimination of duplicate data entry and reconciliation efforts between internal departments and external partners.
• Real-world example: A consortium of mid-sized pharma companies reduced their aggregate annual reporting costs by an estimated $15M by co-funding a shared surveillance platform.

In litigation or regulatory audits, proving the provenance and integrity of safety data is critical and costly. Blockchain provides an indisputable chain of custody for every Adverse Event Report (AER).

• Every data point—from initial report to final submission—is time-stamped, cryptographically signed, and immutable. This creates a forensic-grade audit trail.
• Dramatically reduces legal discovery costs and strengthens defense positions by providing verifiable proof of compliance and data handling procedures.
• Enables automated compliance proofs, instantly generating evidence packs for auditors.

Traditional surveillance relies on batch-processed, stale data, delaying the detection of safety signals. A live, permissioned data hub enables continuous monitoring.

• Smart contracts can be programmed to automatically flag patterns (e.g., a spike in specific adverse events for a drug-lot combination) for immediate investigator review.
• Provides a single, reconciled data source for advanced analytics and AI models, improving the accuracy of risk-benefit assessments.
• Example: Early detection of a regional quality issue could trigger a targeted recall, potentially saving hundreds of millions in liability and brand damage.

Post-market surveillance involves complex ecosystems: API suppliers, CMOs, packagers, and distributors. Data sharing is slow and fraught with trust issues.

• A permissioned blockchain network establishes a standardized, trusted protocol for data exchange between all entities in the product lifecycle.
• Data sovereignty is maintained—each participant controls access to their data via cryptographic keys while contributing to the shared truth.
• Reduces contract disputes and accelerates root-cause analysis in supply chain incidents by providing a synchronized timeline of events across all parties.

Public trust and regulatory relationships are intangible assets at risk during a safety crisis. Proactive transparency is a strategic advantage.

• Enable verifiable transparency by allowing regulators direct, read-only access to anonymized, aggregated safety data, building credibility and streamlining interactions.
• Explore patient-centric models where individuals can securely contribute their health data (via zero-knowledge proofs) to surveillance efforts, creating richer real-world evidence datasets.
• This shifts the industry narrative from obfuscation to collaboration, potentially leading to faster drug approvals and more favorable regulatory treatment.

The investment justification moves beyond cost avoidance to measurable value creation.

• Direct Cost Savings: Reduce FTEs dedicated to manual data aggregation and reporting by 30-50%. Cut audit and legal discovery preparation costs significantly.
• Risk Mitigation Value: Quantify the reduction in potential liability from faster signal detection and stronger audit trails. Early issue detection can prevent billion-dollar recalls.
• Strategic Value: Accelerate time-to-insight for product safety, enabling more informed lifecycle management decisions. The platform itself can become a new revenue line if offered as a service to smaller industry players.

Trace every raw material, component, and batch through the entire supply chain onto the patient. This is critical for root cause analysis during investigations.

• The Pain Point: A recall often requires weeks of manual tracing to isolate a faulty component.
• The Blockchain Fix: Pinpoint the affected batch in seconds, limiting recall scope and saving an estimated $250M+ in a major recall scenario by targeting only impacted units.

Empower patients with control over their health data through self-sovereign identity (SSI). Patients can grant temporary, auditable access to their data for specific studies or monitoring programs.

• Business Justification: Increases patient trust and participation, improving data quality and quantity for studies.
• Future-Proofing: Aligns with evolving global data privacy regulations (GDPR, HIPAA) by design, reducing compliance overhead.

Replace manual, paper-based forms and fragmented databases with a single source of truth. Smart contracts automatically trigger regulatory submissions when adverse events are logged, reducing processing time from weeks to minutes.

• Real Example: A mid-sized pharma company reduced its average reporting time from 45 days to 48 hours, cutting compliance risk and manual labor costs by 70%.
• Key Benefit: Enables real-time signal detection and eliminates costly reconciliation errors between sponsors, CROs, and regulators.

Create a tamper-proof ledger for every data point—from patient report to regulatory acknowledgement. This immutable chain of custody is critical for FDA audits and liability protection.

• Business Justification: Drastically reduces the cost and duration of regulatory inspections. One pilot with a medical device maker showed a 60% reduction in audit preparation time.
• Compliance Edge: Provides verifiable proof of GDPR/21 CFR Part 11 compliance for data integrity, a major selling point for global operations.

Enable secure, permissioned data sharing for safety studies without moving sensitive raw data. Use zero-knowledge proofs to allow researchers to query anonymized, aggregated insights.

• ROI Driver: Monetize dormant safety data by participating in consortium studies. A pilot consortium estimated a $2M annual revenue opportunity from shared analytics.
• Privacy by Design: Patients control consent via digital identities, enhancing trust and meeting evolving privacy regulations, turning a compliance cost into a competitive asset.

Manage the complex web of Contract Research Organizations (CROs), labs, and sites with smart contracts that automate milestone payments and data delivery triggers.

• Cost Savings: A pilot program automated vendor payments against verifiable data delivery, reducing accounts payable overhead by 30% and cutting payment disputes to zero.
• Operational Clarity: All parties access the same real-time status, eliminating the 'black box' of CRO reporting and accelerating study timelines.

De-risk the initiative by limiting the 90-day pilot to post-market surveillance for one recently launched drug in a single regulatory jurisdiction (e.g., FDA).

• Prove Value Fast: Target the highest-volume adverse event reports. Measure success on reduced processing cost per report and time-to-submission.
• CFO-Friendly: Requires minimal upfront CAPEX by leveraging a managed blockchain service, with clear metrics to justify full-scale rollout.

Translate pilot results into financial metrics your CFO demands.

• Hard Savings: 40-70% reduction in manual processing costs for adverse events.
• Risk Mitigation: Near-elimination of fines for late or inaccurate regulatory reporting.
• New Revenue: Access to consortium data pools for advanced analytics.
• The Pitch: Frame the pilot not as an IT project, but as a business process re-engineering initiative with a clear path to 300% ROI within 18 months of full deployment.