Clinical Supply Logistics
Bridging the Gap between CRO and CMO
Maintaining clinical timelines is critical to the successful outcome of a clinical study. That means ensuring that no bottlenecks impede the progress of the study. Far too often, CROs only focus on clinical operations elements, and fail to think about the larger impact of the drug supply chain as it relates to the success of a clinical trial. It is that lack of broader thinking that can lead to drug supply shortages and costly delays at the most critical times of a study. A brilliantly designed study is worthless if no investigational product is available to dose an enrolled subject.
CRMG understands that the clinical supply chain is a necessary and critical factor in ensuring a successful study, which is why we have developed our own clinical supply logistics infrastructure to ensure your drug supply arrives exactly when and where you need it.
Clinical supplies Storage & Distribution
CRMG’s wholly owned clinical trial material distribution facility in the US is based at our Headquarters in Agawam, MA. Our clinical supplies storage and distribution center is a separate, purposely designed cGMP compliant area within our main facility that has the space, systems and procedures to store your investigational products across a wide array of specific conditions.
- cGMP compliant storage facility with controlled access
- Temperature controlled and monitored storage conditions that include:
- Environmental monitoring and alarm systems
- Back-up emergency power
- Inventory management services
- Customized range of pre-qualified shipping solutions to ensure the integrity of temperature sensitive products from ambient to -70°C
- Experience and relationships with a variety of qualified couriers to support your global transportation requirements
- Same day turn-around for shipment requests
Returns, Accountability and Destruction
An important element to properly closing out a clinical study is assuring accountability for all investigational products. CRMG provides complete and appropriately documented returns, with accountability and destruction services that are protocol-specific, ensuring the appropriate level of accountability required for your study.
Our services include:
- Oversight of returns process, with the capacity to handle any volume of global drug returns for all phases of development
- Protocol-specific set up to capture the level of accountability required by sponsors
- Returns and reconciliation report
- Coordination of incineration of returned or quarantined supplies
- Certified destruction of materials
Clinical Supply Chain Consulting Services
At CRMG, we understand that clinical logistics support is more than just the act of storing and distributing investigational material. To that end, our clinical supply chain consultants are highly experienced logistics professionals ready to help support the management of your clinical supply chain by providing the following value added services:
- Investigational material planning and forecasting
- Distribution and depot strategy
- Patient kit design
- Label development and translation
- IXRS evaluation and selection
- Randomization generation
- Comparator sourcing
- Procurement of ancillary supplies
- Supply chain management and re-forecasting
Benefits of Using CRMG for your Clinical Logistics Needs
- By combining clinical operations and supply logistics under one roof, you are afforded a unified team that looks at the holistic elements of your trial, efficiently managing your clinical supply chain based on real time data, and adjusting clinical supply strategies to make sure product is at sites when needed.
- Reduction in the number of vendors in your overall clinical study provides a more efficient and cost effective way of managing the clinical outsourcing process, and eliminates the potential for gaps in communication between separate clinical operations and supply chain organizations.