Drug Supply Management

Demand Forecasting & Supply Planning

• Use historical data, recruitment rates, and trial design to forecast drug supply needs.
• Develop supply chain models to determine the right amount of drug needed at each site.
• Implement Just-in-Time (JIT) supply strategies to minimize waste and reduce storage costs.

Manufacturing and Packaging Support

• Coordinate with Contract Development and Manufacturing Organizations (CDMOs) to ensure drugs are produced and packaged on time.
• Manage packaging and labeling requirements based on regulatory guidelines (e.g., multilingual labels, country-specific requirements).
• Ensure blinded and unblinded packaging strategies to maintain trial integrity.

Interactive Response Technology (IRT) Integration

• Implement IRT systems (e.g., IWRS/IVRS) to automate drug assignment, tracking, and resupply.
• Configure IRT algorithms to trigger automated shipments based on real-time site inventory levels.
• Integrate IRT with Electronic Data Capture (EDC) and Clinical Trial Management Systems (CTMS) for seamless data sharing.

Inventory Management & Distribution

• Monitor inventory levels at depots, sites, and pharmacies to prevent stock shortages or overages.
• Ensure timely shipments from central depots to clinical trial sites, using temperature-controlled logistics when required.
• Manage drug accountability and reconciliation, ensuring accurate tracking of dispensed, returned, and destroyed drugs.

Cold Chain & Temperature-Controlled Logistics

• Oversee cold chain management for biologics, cell therapies, and other temperature-sensitive drugs.
• Work with specialized couriers (e.g., Marken, World Courier) to ensure controlled temperature transport.
• Implement real-time temperature monitoring to track deviations and ensure drug stability.

Regulatory Compliance & Quality Assurance

• Ensure GMP (Good Manufacturing Practice) and GDP (Good Distribution Practice) compliance across the supply chain.
• Maintain audit trails for regulatory bodies like FDA, EMA, MHRA, and PMDA.
• Prepare documentation for Investigational Medicinal Product Dossier (IMPD) and other regulatory filings.

Site Support & Resupply Optimization

• Provide training to site staff on drug handling, storage, and accountability procedures.
• Automate resupply strategies to ensure continuous drug availability while minimizing overstock.
• Monitor expiry dates and facilitate re-labeling or re-supply of expiring products.

Drug Returns, Reconciliation & Destruction

• Track and manage unused investigational drugs, ensuring proper documentation and compliance.
• Coordinate with specialized vendors for drug destruction or returns as per regulatory requirements.
• Conduct final reconciliation to ensure no discrepancies before closing the trial.

Risk Management & Contingency Planning

• Identify potential risks (e.g., supply chain disruptions, regulatory changes, manufacturing delays).
• Develop contingency plans such as backup suppliers, alternative depots, or protocol modifications.
• Monitor global supply chain conditions to mitigate potential disruptions.

Cost Optimization & Waste Reduction

• Implement lean supply strategies to minimize drug wastage and optimize trial budgets.
• Use adaptive supply models to adjust inventory needs dynamically as recruitment progresses.
• Help sponsors avoid unnecessary overproduction while ensuring patient treatment continuity.