Although the supply chains supporting clinical trials are some of the most intricate in the life sciences sector, they constitute the cornerstone of medical innovation. Conventional bulk manufacturing and static supply models are no longer adequate for the increasingly global, decentralized, and patient-centered nature of modern trials. Enter On-Demand and Just-in-Time (JIT) manufacturing two strategies that are revolutionizing how investigational medicinal products (IMPs) are produced, packaged, and delivered. These models bring unprecedented efficiency, precision, and responsiveness to clinical trial logistics. World BI is organizing Clinical Trial Supply Forum again where this topic is going to be discussed.
Understanding On-Demand and JIT in Clinical Trials
What is On-Demand Manufacturing?
Clinical trials that use "on-demand manufacturing" produce or package investigational materials exclusively in response to specific orders or demands, which are frequently prompted by site requirements, protocol changes, or real-time patient enrollment.
- Custom-labeling per site or country
- Last-minute packaging changes
- Real-time distribution based on need
What is Just-in-Time (JIT) Manufacturing?
JIT manufacturing ensures that materials and products are delivered exactly when needed not earlier, not later. Just-in-time (JIT) supply chains are a type of inventory management system where raw materials, parts and other resources are ordered and delivered as needed by the manufacturer. Ideally, the JIT supply chain streamlines production flow and eliminates redundant costs associated with maintaining large inventory stockpiles. When used correctly, this supply chain strategy can reduce lead times, improve quality control and increase efficiency.
- Drug products to trial sites
- Kits and ancillary supplies
- Cold chain items with limited stability
JIT facilitates a reduced inventory model by closely coordinating production, packaging, and distribution with patient enrollment information and trial milestones.
The JIT inventory system works by minimizing inventory and increasing efficiency. It hinges on a harmonious supply chain, precise demand forecasting, and Supply Chain Inventory Optimization.
Why Traditional Supply Models Are Falling Short?
Conventional clinical trial supply models rely heavily on forecasting and bulk manufacturing often resulting in:
- Overproduction
- Excess inventory
- Wastage due to expiry
- Limited flexibility in adapting to changes
These issues are aggravate in trials that are:
- Adaptive in design
- Decentralized with multiple countries or patient homes involved
- Personalized, such as cell and gene therapy trials
This is where On-Demand and JIT models offer a smarter solution.
Benefits of On-Demand and JIT in Clinical Trial Supply
1. Reduced Waste and Lower Costs
Manufacturing or packaging products only when needed minimizes drug wastage, especially critical for:
- High-value biologics
- Short-shelf-life therapies
- Personalized medicine
2. Increased Flexibility and Responsiveness
Trials often go through protocol changes or face enrollment delays. On-Demand/JIT manufacturing allows sponsors to:
- Adapt labeling or packaging late in the process
- Respond to fluctuating patient recruitment
- Minimize rework and resupply costs
3. Improved Patient-Centricity
As more trials go decentralized, sponsors need to ship directly to patients or nearby sites. On-Demand models support:
- Smaller, more frequent shipments
- Patient-specific kitting and delivery
- Better adherence to cold chain and GxP standards
4. Enhanced Regulatory Compliance
Regulatory requirements differ across countries. On-Demand labeling allows for:
- Country-specific labels on short notice
- Reduction in relabeling errors
- Real-time QA/QP release
This flexibility ensures better global compliance.
5. Real-Time Inventory Management
With integrated software and digital tools, JIT models offer real-time visibility into:
- Inventory levels
- Shipment tracking
- Site consumption
Real-World Use Cases in Clinical Trials
1. Adaptive Trial Designs
Adaptive trials involve frequent changes in patient cohorts, dosing, or protocols. On-Demand manufacturing allows:
- Rapid adjustment of packaging and supply plans
- Support for staggered dosing arms
2. Personalized and Cell Therapy Trials
Gene and cell therapies are often patient-specific and require:
- Real-time coordination between collection, manufacturing, and reinfusion
- Tight control over identity and timing
JIT is crucial to ensure cold chain integrity and successful patient outcomes.
3. Global Multisite Trials
Large trials with sites across multiple countries require:
- Local language labeling
- Compliance with varying import regulations
On-Demand labeling and JIT distribution enable sponsors to scale efficiently across regions.
4. Direct-to-Patient (DTP) Delivery
As trials decentralize, sponsors must ship directly to patients’ homes. On-Demand kitting and JIT delivery ensure:
- Correct patient-specific kits
- Real-time tracking and temperature control
- Compliance with chain of custody
Enablers and Technologies Supporting JIT & On-Demand
To implement JIT and On-Demand successfully, sponsors are leveraging:
- Clinical Supply Management Platforms
- Randomization and Trial Supply Management
- Digital Labeling Systems
- Cold Chain Monitoring Devices
- Flexible Manufacturing Facilities
Challenges to Consider
Despite their advantages, these models come with challenges:
- Lead Time Sensitivity: Delays in manufacturing or QA release can cause site shortages.
- Vendor Coordination: JIT requires tight synchronization among CROs, CMOs, and depots.
- Technology Integration: Real-time visibility and automation are essential, requiring strong IT infrastructure.
- Risk of Stockouts: Without buffer stock, any disruption can delay patient dosing.
Prospects for the Future
The clinical trial industry is moving towards:
- Smaller, more targeted studies
- More global and diverse patient pools
- Increased use of real-time data and digital tools
As a result, On-Demand and JIT manufacturing will become foundational to future clinical trial supply strategies:
- Faster trial starts
- Higher patient satisfaction
- Greater ROI on investigational products
Conclusion
For contemporary clinical trial supply chains, Just-in-Time (JIT) and On-Demand (ODD) production are strategic requirements rather than fads. These methods facilitate increased productivity, flexibility, and patient-centeredness by coordinating output with actual demand. In an era where speed, flexibility, and precision are crucial, embracing On-Demand and JIT manufacturing could be the difference between trial success and failure.
World BI Clinical Trial Supply Forum
Clinical Trial Supply Forum is a global event uniting leading pharmaceutical, biotech, and clinical research organizations along with AI, data science, regulatory, and clinical operations experts to explore the future of clinical supply. Clinical Trial Supply Forum Organized by World BI, this dynamic conference focuses on clinical trial design, Clinical Supply Planning & Forecasting, Risk-based supply planning, decentralized trials, real-world data, Clinical drug product manufacturing, JIT, Cold chain and controlled room temperature logistics, Randomization, Supply chain simulation and trial supply management and AI-driven innovations in clinical research. The event fosters cross-industry collaboration and innovation to enhance the efficiency, diversity, and success of clinical trial supply globally.