End-to-End Investigational Product Provenance

The illicit drug trade costs the global economy over $200B annually. Blockchain provenance assigns a unique digital identity (NFT) to each product unit, serialized at the point of manufacture.

• Track-and-trace in real-time: Every scan by a distributor, pharmacy, or clinic verifies authenticity and logs location.
• Instant verification: Healthcare providers can confirm drug legitimacy via a simple QR code scan before administration.
• Case study: The MediLedger Project, involving Pfizer and Genentech, demonstrated a blockchain network that could verify prescription drug returns, preventing counterfeit re-entry into the supply chain.

Ensures tamper-proof tracking of investigational drugs from the manufacturer to the clinical site. This eliminates manual reconciliation errors and provides an immutable audit trail for regulators like the FDA.

• Real Example: A top-10 pharma company reduced drug reconciliation time by 70% and cut supply chain losses by an estimated 15% annually.
• Key Benefit: Automated compliance reporting slashes audit preparation from weeks to hours.

Links specific drug batches and doses to individual patient kits and administration events. This creates a single source of truth for patient safety and protocol adherence.

• Real Example: A global CRO implemented this to instantly trace adverse events back to specific manufacturing lots, reducing investigation time from days to minutes.
• Key Benefit: Drastically improves patient safety monitoring and provides irrefutable data for regulatory submissions.

Integrates IoT sensors with blockchain to automatically record storage conditions (temperature, humidity) for temperature-sensitive biologics. Data is written immutably upon any threshold breach.

• Real Benefit: Eliminates manual log errors and provides defensible proof of custody. Prevents the costly destruction of compromised shipments, which can represent millions in R&D loss.
• ROI Driver: Direct cost avoidance by validating chain of condition, protecting product viability and trial integrity.

Manages the complex reverse logistics of unused or expired trial drugs with automated compliance workflows. Every return and destruction event is permanently recorded.

• The Pain Point: Manual processes are error-prone and create significant regulatory risk.
• The Blockchain Fix: Provides a verifiable, automated ledger that satisfies stringent requirements from the DEA and other agencies, reducing compliance overhead and audit findings.

Secures the supply chain against the introduction of counterfeit investigational products. Each unit has a unique, cryptographically-secured identifier verified at every handoff.

• Business Impact: Protects patient safety, trial validity, and the sponsor's intellectual property. A single counterfeit incident can invalidate a multi-million dollar trial.
• Strategic Value: Builds trust with regulators and investigators by demonstrating proactive risk management.

Blockchain acts as a neutral data layer, seamlessly connecting disparate systems (CTMS, EDC, IVRS) without replacing them. It synchronizes product movement data with patient enrollment and dosing schedules.

• ROI Justification: Eliminates costly, custom point-to-point integrations and reduces IT maintenance. Provides sponsors with a real-time, holistic view of trial supply status versus patient demand, optimizing inventory and reducing waste.