In the dynamic clinical research world, efficiently and compliantly delivering supplies to trial sites is no small feat—especially when navigating multi-country, multi-site, or high-complexity studies. The clinical trial supply chain must be agile and precise, supporting global regulations, temperature-sensitive drugs, tight timelines, and ever-evolving protocols. These challenges require more than logistics—they demand deep expertise, collaboration, and technological integration.
This is where Contract Development and Manufacturing Organizations (CDMOs), like Experic, offer comprehensive support to manage clinical trial supply complexities from formulation to final delivery.
Key Challenges in Clinical Trial Supply Logistics and Compliance
1. Global Distribution Complexity
Managing clinical trial supply across different countries means facing a patchwork of customs regulations, labeling standards, import/export restrictions, and local language requirements. Failing to comply can delay trial progress, compromise product integrity, or invalidate results.
2. Temperature-Controlled Storage and Shipment
Many investigational products require stringent storage conditions, including cold chain logistics. These add layers of complexity—from specialized packaging and temperature monitors to validated shipping routes and contingency planning.
3. Real-Time Inventory Management
Clinical sites often struggle with overstocking or understocking due to limited visibility into inventory. This can lead to product wastage or, worse, dosing interruptions.
4. Trial Design and Protocol Amendments
Adaptive trials and protocol changes mid-study can trigger a domino effect in supply needs—requiring repackaging, relabeling, or reshipment on short notice.
5. Patient-Centric Distribution
Decentralized trials and direct-to-patient (DTP) models introduce last-mile logistics challenges, where maintaining a chain of custody and privacy becomes crucial.
6. Regulatory Compliance and Audits
Clinical trial supply operations must comply with Good Manufacturing Practices (GMP) and Good Distribution Practices (GDP), and they often face scrutiny during inspections or audits by regulatory bodies such as the FDA or EMA.
How CDMOs Help Streamline Distribution, Storage, and Supply Chain Management
Partnering with a CDMO with deep clinical supply expertise brings efficiency, agility, and reliability to your trial operations. Here’s how:
End-to-End Integration
CDMOs like Experic combine manufacturing, packaging, labeling, and logistics under one roof, enabling seamless transitions between phases and reducing the risk of miscommunication or delays.
Global Logistics & Storage Capabilities
With a purpose-built 73,000 sq. ft. facility and global distribution capabilities, Experic manages temperature-controlled storage and international shipping with real-time tracking to ensure products arrive in spec and on time.
Tailored Supply Strategies
From small Phase I studies to global Phase III trials, CDMOs develop bespoke supply plans that factor in forecast accuracy, packaging formats, and country-specific regulations. Experic’s collaborative project management and real-time visibility allow quick pivots in response to study changes.
Speed and Flexibility
Experic is designed to facilitate rapid onboarding and collaboration. Clients can even work side-by-side with experts during planning and execution—an approach that fosters innovation and builds confidence.
Compliance-First Execution
CDMOs ensure that every supply activity is audit-ready and fully documented, reducing sponsor risk and improving trial outcomes, from GMP packaging to GDP-compliant logistics.
Why Strategic Partnerships Matter in Clinical Trial Supply
No sponsor can afford to risk clinical delays due to preventable supply chain issues. Clinical trial supply is a strategic function—not just a logistical task. It affects trial continuity, regulatory success, and, ultimately, time to market.
With unmatched expertise in powder handling, cutting-edge clinical manufacturing technology, and integrated services from formulation through distribution, Experic helps sponsors of all sizes confidently navigate complexity.
Explore Experic’s Clinical Trial Supply Services to see how our team can support your next study with agility, expertise, and precision.
Bringing Experience to Deliver Under Pressure
As clinical trials become increasingly global, decentralized, and personalized, the complexity of the supply chain will only rise. Sponsors require partners who offer more than just logistics—they need experience, insight, and a demonstrated ability to perform under pressure.
Partner with Experic to transform clinical trial supply from a potential bottleneck into a competitive advantage.