Clinical Label Management
MRIGlobal maintains a supply chain management repository and stability facility with all requisite space and equipment.
Our operational areas are optimized for the functional activity and workflow specific to the drug agents being processed. Each contiguous area within the repository consists of dedicated space for receipt, agent management, quarantine, dispensing, labeling, packaging, and distribution.
Capabilities
- GMP full-service repository – receipt, test, store, aliquot, and ship
- Clinical trial label design
- Customized clinical supply kits including placebo for blinded studies with over-encapsulation capabilities
- On-site drug distribution license
- Analytical support – identity confirmation and comprehensive API and drug product testing, including ICH stability testing
- Worldwide distribution and cold chain management; more than 1,500 investigational agents shipped
- Repository for an oncology portfolio of more than 4,000 compounds
- Facilities maximize workflow efficiency and maintain the integrity of client products
- All work is performed in strict accordance to federal regulations
- 10,000 ft2 of secure storage space
- Validated and temperature mapped storage
- −150°C; −80°C; −30° to −10°C; 2° to 8°C; ambient continuous monitoring and alarm system
- Inert fire suppression system
- High potency containment areas
- Automated backup generator to support the entire facility in the event of a power outage
Our Staff
Over the past eight years, our team has shipped more than 1,500 deliveries without incident to domestic and international destinations for clinical research sites.
We maintain a drug distribution license and certifications for shipment of dangerous goods according to DOT and IATA regulations. Repository support personnel hold pharmacy technician licenses and go through extensive training in DOT and IATA shipping regulations.
Work with us
MRIGlobal looks forward to contributing our expertise where it matters most.
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