Decentralized Real-World Evidence Exchange

Manual data reconciliation and site monitoring consume 30-40% of a trial's budget. A shared, immutable ledger automates patient data flow from EHRs and wearables, creating a single source of truth.

• Example: A sponsor reduced patient enrollment verification from 45 days to <72 hours by using a permissioned blockchain to instantly validate eligibility criteria across 50+ sites.
• ROI Driver: Cut monitoring visits by 60% and accelerate study completion by 25%, saving millions per trial.

Hospitals and research sites generate valuable data but lack a secure, compliant marketplace. Tokenizing de-identified datasets on-chain creates auditable data provenance and enables micro-licensing.

• Example: A hospital consortium monetizes its oncology treatment dataset by selling granular, permissioned access to pharma researchers, generating a new seven-figure revenue stream with full patient privacy compliance (HIPAA/GDPR).
• ROI Driver: Transform a cost center (data storage) into a profit center with clear audit trails for every data transaction.

Regulatory submissions (FDA, EMA) require exhaustive data lineage proof. Manual assembly is error-prone and costly. Blockchain provides an immutable chain of custody for every data point from source to submission.

• Example: A medical device company reduced its audit preparation time for a PMA submission from 6 weeks to 3 days by leveraging smart contracts to auto-generate compliance reports from the on-chain evidence ledger.
• ROI Driver: Eliminate 90% of manual audit prep work and significantly reduce regulatory risk and potential fines.

Post-market safety signal detection is slow due to fragmented adverse event reporting. A decentralized network enables real-time, tamper-proof data pooling from pharmacies, providers, and patients.

• Example: By connecting to a global RWE exchange, a pharmacovigilance team identified a rare side effect pattern 8 months earlier than traditional methods, enabling proactive label updates and mitigating litigation risk.
• ROI Driver: Faster signal detection reduces potential liability costs and protects brand value by demonstrating proactive safety management.

Healthcare's biggest cost is integration. Legacy HL7/FHIR APIs create brittle, point-to-point connections. A blockchain acts as a neutral data utility layer, allowing disparate systems (EHRs, CROs, labs) to exchange verified data without a central aggregator.

• Example: A health system integrated its Epic EHR with three different CRO platforms in weeks, not years, by adopting a common blockchain protocol, eliminating custom interface builds.
• ROI Driver: Reduce system integration costs by over 70% and future-proof data architecture against vendor lock-in.

Patient recruitment and retention are major trial bottlenecks. Blockchain empowers patients with self-sovereign health data control. They can grant granular, time-bound access to their data and be compensated directly via smart contracts.

• Example: A decentralized trial platform saw a 40% higher retention rate by allowing patients to own their data wallet and receive micro-payments for completed diary entries and sensor data uploads.
• ROI Driver: Higher retention improves data quality, reduces recruitment costs, and builds a trusted brand for patient-centric research.

The Pain Point: Patient recruitment and data verification can delay trials by 6-12 months, costing sponsors millions. Siloed data from hospitals, labs, and wearables creates compliance nightmares.

The Blockchain Fix: A permissioned ledger creates a single, immutable source of truth for patient eligibility and trial milestones. Smart contracts automate data-sharing agreements and payments to trial sites upon verified milestone completion.

Real-World Impact:

• 30-50% faster patient cohort identification via auditable data queries.
• Automated audit trails reduce manual compliance overhead by up to 70%.
• Example: A top-10 pharma company piloted this to cut Phase III trial setup time by 40%.

The Pain Point: Regulatory bodies (FDA, EMA) demand complete, tamper-proof audit trails for all clinical data. Manual processes are error-prone and vulnerable to fraud.

The Blockchain Fix: Every data point—from lab results to patient consent—is hashed and timestamped on-chain, creating an immutable provenance chain. Regulators can verify data lineage in real-time.

Real-World Impact:

• Guaranteed data integrity for GCP (Good Clinical Practice) and ALCOA+ principles.
• Near-instant audit readiness slashes preparation time from weeks to hours.
• Example: A medical device firm used this to streamline its FDA pre-market submission, avoiding costly data integrity queries.

The Pain Point: Hospitals and research centers sit on valuable Real-World Data (RWD) but lack secure, compliant mechanisms to license it without risking patient privacy or IP.

The Blockchain Fix: A decentralized exchange allows data custodians to list tokenized, anonymized data sets. Access is governed by smart contracts that enforce usage terms, automate royalty payments, and track all data usage.

Real-World Impact:

• Creates new revenue streams for healthcare providers from dormant data.
• Patients can opt-in and share in revenue via micro-royalties, improving engagement.
• Example: A European hospital consortium launched a data marketplace, generating €2M+ in its first year from licensed RWD.

The Pain Point: Tracking drug safety and effectiveness after launch relies on fragmented, delayed reports, making it hard to detect adverse events or prove real-world efficacy to payers.

The Blockchain Fix: A unified evidence ledger aggregates anonymized outcomes data from pharmacies, insurers, and patient apps. Smart contracts trigger alerts for safety signals and generate verifiable Real-World Evidence (RWE) reports.

Real-World Impact:

• Faster, more reliable pharmacovigilance enhances patient safety.
• Verifiable RWE strengthens value-based pricing negotiations with insurers.
• Example: A biotech company used this system to demonstrate superior drug performance in a real-world population, securing favorable formulary placement.