The complexity of clinical trials require in time delivery of the investigational products as well as other critical components, CBCC-Vibgyor offers storage, distribution and labeling solutions to our sponsors.
Our Clinical Supplies Service includes following:
We design, print and apply labels in the appropriate languages; assemble study kits; distribute to study sites, in a seamless and cost-effective manner ensuring compliance and accuracy.
Label Design and Production
Regulatory labeling requirements differ with region. We provide regulatory compliant, quality controlled high-quality labels
Storage and Distribution, transportation management
We offer a wide range of temperature controlled storage conditions for your investigational products and ensure temperature controlled transfers of the IP in order to ensure optimal product protection transfer. Our full-scale offering includes: courier selection and management, import/export advice and support, customs and regulatory guidance, GMP storage and distribution facilities, global quality assurance support, and proactive track and trace of clinical supplies across the supply chain.
Returns and Destruction
We can track accountability of the drug from the sites and take care of the destruction of unused IP of supplies including controlled and hazardous drugs.
Ancillary Supply Management
Materials such as the needles and tubing required to administer an IV drug to larger equipment such as freezers and ECG machines or even nutritional supplements materials, that are required as part of the treatment stipulated in the protocol, though are not considered Investigational Product, are equally important for efficient trial operations.
We understand the importance of handling the supplies from a single point. Our team facilitates supply and transport of these ancillary materials to the sites, handling all the requirements in terms of customs and import stipulations.
Biological Specimen Management
We can procure any biological specimen, preserve the specimen as per protocol defined requirements and also can preserve the specimens from the time they are procured till the time they are needed. We can undertake management of samples for studies, vaccines and bulk drugs for the study term and beyond, marinating the stringent criteria throughout its life cycle.
We can provide the following temperature-controlled conditions:
- Refrigerated (2˚C to 8˚C)
- Freezer (-25˚C to -10˚C)
- Ultra-low Freezer (-95˚C to -70˚C)
- Vapor-Phase Liquid Nitrogen (-150˚C to -135˚C)
- Liquid-Phase Liquid Nitrogen (-196˚C)
Cold Chain Services
We provide best in class shipping solutions for cold-chain packaging and distribution, enabled through partnerships with manufacturers and industry suppliers