Decentralized Randomization & Trial Supply Service

Manual audit trails for patient randomization and drug supply are slow, expensive, and error-prone. Our immutable, timestamped ledger automates this process, creating a single source of truth. This cuts audit preparation time by up to 70% and reduces associated administrative costs. For a global Phase III trial, this can translate to savings of $500k+ in compliance overhead alone.

Centralized randomization can create bottlenecks, delaying patient enrollment and site activation. Decentralized, on-chain randomization enables instant, verifiable assignment across all global sites simultaneously. This removes coordination lag, potentially shortening enrollment phases by 15-20%. Faster enrollment means your drug reaches market sooner, capturing critical revenue earlier.

Opaque supply chains lead to counterfeit risks, temperature excursions, and significant drug wastage. A tokenized trial supply service tracks each unit from manufacturer to patient with cryptographic proof. This ensures authenticity, optimizes inventory, and reduces waste. Real-world pilots have demonstrated a 25% reduction in wasted investigational product, protecting millions in drug development costs.

Regulators and partners demand unprecedented transparency. A tamper-proof audit trail for every randomization event and supply chain movement builds inherent trust. This demonstrable integrity can streamline regulatory submissions and strengthen partnerships. It directly addresses FDA guidance on Computerized Systems Used in Clinical Investigations, turning a compliance burden into a competitive advantage.

Manual reconciliation of patient enrollment milestones and site payments is administratively heavy. Smart contracts can automatically trigger payments to clinical sites upon verifiable on-chain events (e.g., confirmed randomization). This improves site satisfaction, accelerates payment cycles from 90+ days to near-instant, and reduces accounts payable workload.

The shift to hybrid and fully decentralized trials requires robust, remote integrity tools. Blockchain-based randomization and supply are foundational for DCTs, enabling direct-to-patient logistics and verifiable remote consent. Early adoption positions your organization as a leader, avoiding costly retrofits later. Example: A virtual cardiology trial used this model to cut site visit costs by 40% while maintaining audit readiness.

Replace manual, error-prone randomization with a tamper-proof, auditable process. A smart contract acts as the central randomization service, assigning patients to treatment arms based on cryptographically secure, verifiable entropy. This ensures:

• Unbreakable blinding for trial integrity.
• Instant audit trail for regulators (FDA, EMA).
• Elimination of manual errors and associated rework costs.

Example: A Phase III oncology trial reduced randomization setup time by 70% and eliminated all reconciliation queries from monitors.

Track every unit of Investigational Product (IP) from manufacturer to patient return/destruction on an immutable ledger. Each vial or kit receives a digital twin, recording:

• Chain of custody across depots and sites.
• Temperature logs (integrated with IoT).
• Patient dispensing and returns.

This automates the costly and complex drug reconciliation process, providing real-time visibility and reducing the risk of stock-outs or expiry. CFOs see direct ROI through reduced waste and lower labor for manual tracking.

Automate clinical site milestone payments and patient stipends triggered by on-chain events. When a patient is successfully randomized or a visit is verified, a smart contract automatically releases payment, reducing administrative overhead by up to 50%. This system provides:

• Transparent financial flows for sponsors and sites.
• Automated compliance with payment terms.
• Faster site reimbursement, improving site relationships and trial enrollment rates.

Real-world impact: A multi-center trial cut payment processing time from 45 days to 48 hours.

Generate a single source of truth for trial conduct. Every critical action—randomization, drug shipment, patient consent—is timestamped and hashed on the blockchain. For audits or regulatory submissions, sponsors can provide:

• Irrefutable evidence of protocol adherence.
• Instant data lineage from source to submission.
• Dramatically reduced preparation time for FDA or EMA inspections.

This transforms a reactive, costly audit process into a proactive compliance asset, justifying the technology investment through risk mitigation and operational savings.

Transform a costly, manual process into an automated workflow. Smart contracts can manage return authorization, verify product history, and trigger destruction protocols or credit issuance. This creates a closed-loop system that enhances patient safety and operational efficiency.

• Example: A pilot program automated returns reconciliation, cutting processing time from weeks to hours and improving financial accuracy.
• ROI Driver: Drastically reduces administrative overhead, accelerates financial reconciliation, and improves patient safety protocols.

Demonstrate unprecedented transparency in drug provenance and trial data integrity. Provide payers with verifiable proof of value (e.g., real-world evidence, supply integrity) to support pricing and reimbursement discussions. Build provider confidence in your supply chain's reliability.

• ROI Driver: Strengthens market access negotiations, reduces payer disputes, and enhances brand equity as a leader in transparency.

Our structured 90-day pilot focuses on a single drug SKU or trial protocol to quantify benefits with minimal upfront investment. We provide the infrastructure, integration support, and a clear metrics dashboard to measure:

• Cost Savings (reduced fraud, manual labor)
• Efficiency Gains (faster processes, automated compliance)
• Risk Reduction (audit readiness, supply security) The deliverable is a business case with hard ROI data to justify enterprise-wide scaling.