Global Storage and Distribution

Clinigen Clinical Supplies Management has a highly qualified network of approved global partners to support your international clinical trial storage, shipping, and distribution processes. This provides you with the most time-efficient and accurate clinical trial logistics solutions.

With partners strategically located around the globe, our clinical storage and distribution processes allow for facilities to manage the seamless shipping, and custom release, of your clinical trial supplies.

We have 25+ years of experience and expertise in storage and distribution solutions to fully support the needs of your global clinical trials. The Clinigen team has managed the clinical supply chain for over 700 global trials, including those requiring cold chain logistics. Our network consists of multiple own facilities and sites in the US, EU, South Africa and Asia Pacific regions, with extended operations through other key logistical site locations.

We realise the wide range of storage conditions you will need throughout the life cycle of your study. Clinigen’s cGMP storage facilities, as well as our cold chain storage and distribution services, offer a variety of controlled environmental conditions to accommodate your clinical trial’s unique supply demands.

We offer a variety of clinical trial storage and distribution services including:

• IVRS Support
• Temperature-Controlled Storage
• Controlled Drug Storage
• Receiving
• Labelling
• Distribution
• Temperature-Controlled Shipping
• Returns/Reconciliation/Destruction
• QP Services
• Import and Customs Clearance
• Full Order Management and Inventory Tracking
• Logistics Services

Our qualified depots are defined and strengthened by multiple QA audits that assure safe and accurate delivery of your clinical trial supplies.

Additionally, Clinigen is IATA and ADR certified for air and road transport of dangerous goods.

Global Clinical Trial Distribution Capabilities:

• Qualified Global Depots
• QP Release Services
• Global Packaging, Labelling, and Storage Capacities
• Temperature Controlled Shipping of Products Worldwide
• Stock Inventory Management System (SIMS)
• Secure 24/7 Worldwide, Web-Based Inventory Management System

Cold chain storage and distribution

Clinigen has an extensive, global, and focused, list of available packaging, labelling, storage, and distribution services for all of your temperature-sensitive requirements worldwide.

Also, our team can easily arrange for the retrieval of your clinical trial products as well as the delivery of your clinical trial’s products through temperature-controlled shipping solutions.

Clinigen strives to meet every clients’ needs in a personal manner. We do this by working closely with every client we serve to develop a seamless cold chain logistics plan that will meet your clinical trial's exact and specific needs. Our validated shipping systems provide safe and efficient solutions along the entire cold supply chain.

Cold Supply Chain Logistics for Clinical Trials

• Temperature-Controlled Trucks
• Pallet-Sized Temperature-Controlled Shippers
• Validated Re-Usable Shippers for 96 to 120 Hours
• Temperature Range of 2-8°C, -20°C and -50°C
• Dry Ice (-70°C) or Gel Pack Shippers (2-8°)
• Cryogenic Shippers

GMP/CGMP storage facilities and storage systems

We realise the wide range of clinical trial storage capabilities you will need throughout the life cycle of your study. Clinigen’s storage facilities and storage systems are GMP/cGMP-compliant and offer a variety of controlled environmental conditions to accommodate your clinical trial requirements.

To ensure your clinical materials are well protected, we have a 24/7 environmental monitoring and security system as well as controlled access throughout our facilities.

CEMS (Central Enterprise Management System), our proprietary ERP tool manages project operations across the different locations and continents allowing clients to track warehouse and site inventories in real-time.

Additionally, eCEMS is a web application for customers and sites, showing an inventory of products, biospecimens, details of distributions, and allowing the ability to place distribution orders as well as to schedule reports.

Available GMP/CGMP Storage Conditions for Clinical Trial Supplies:

• Controlled Room Temperature and Relative Humidity (20° to 25°C)
• CFT Drive-in Refrigerator (2° to 8°C)
• Walk-in Refrigerators (2° to 8°C)
• Walk-in Freezers (-10° to -25°C)
• Walk-in Deep Freezer (-20° to -40°C)
• Ultra-Low Freezers (-70°C or Colder)
• Cryogenic Storage (Vapor and Liquid)
• DEA Storage Vault, Safe & Cage
  Controlled Substance (CII – CV) Handling
• CRT - Pallet Capacity

Global distribution capabilities for clinical trials

To support your international clinical study, in addition to our own sites across the world, Clinigen has a network of approved global partners.

Our partners are strategically positioned around the world, allowing for seamless shipping and customs release of your clinical trial supplies.

Global Clinical Distribution Capabilities:

• Qualified Global Depots
• QP Release Services
• Temperature Controlled
• Shipping Worldwide
• Stock Inventory
• Management System (SIMS)
• Secure 24/7 Worldwide,
• Web-Based Inventory
• Management System

Clinical trial shipping solutions

Clinigen Clinical Supplies Management ensures the safe delivery of your temperature-controlled clinical products worldwide. This is done by effectively accommodating a wide range of environmental conditions to protect your clinical trial materials during domestic, as well as international, transit.

Clinigen currently handles clinical trial supply shipments to approximately 110 countries, creating a positive difference in the experience and understanding of clinical supply shipping solutions versus that of any other clinical supply management company.

Whether your materials are shipped from your manufacturer to Clinigen, Clinigen to clinical sites, or back to our reconciliation department, we provide temperature-controlled and monitored shipping.

Our temperature monitoring solutions include single-use, multi-use, or active web-based monitoring for real-time details on your shipment, including location and when the package is opened.

Shipping Solutions for Clinical Trials:

• Temperature-Controlled Trucks
• Pallet-Sized Temperature-
• Controlled Shippers
• Validated Re-Usable
• Shippers for 96 to 120 Hours
• Temperature Range of CRT, 2-8°C, -20°C
  and -50°C
• Dry Ice (-70°C) or Gel Pack Shippers (2-8°)
• Validated for 48 Hours
• Cryogenic Shippers