Creating individual solutions to answer your unique challenges
Cryoport Systems can manage your clinical supplies through every step of your clinical trial
Even before a trial has started, sponsor companies can significantly improve their returns process. Providing clear and concise instructions to investigator sites from day one, like setting out the processes by which samples should be returned, is vital to ensure a smooth returns process. Clear expectations should always be set for the parties providing returns management services to makes sure any returns are processed promptly. Cryoport Systems can manage your clinical supplies through every step of your clinical trial.
Let Cryoport Systems manage your clinical supplies
To ensure traceability of all therapeutic materials for a robust returns and reconciliation process
Clinical trial sponsors must account for all doses of investigational drug products from the point of manufacture to the administration or the final certified disposition and destruction, but the return and destruction of unused investigational drugs at the end of a clinical trial is often overlooked. Regardless of the size of your study, all doses of a drug must be accounted for at the close of your trial. This may involve accountability all the way down to the individual dose level and include detailed recordkeeping. Early discussion and planning for returned drug accountability is important and a necessary element of clinical supplies management planning.
Cryoport Systems will competently manage your clinical supplies through every step of your clinical trial even when changes occur. We can be counted on for clear and concise communication throughout your clinical study development process to ensure traceability of all therapeutic materials to help you create a robust returns and reconciliation process.
BioServices for Clinical Trial Materials
Cryoport Systems’ BioServices solutions encompasses the return, storage, and ultimate disposal or return of clinical trial materials at the end of your project. Returns can be reconciled to different levels before being securely stored until the approval for destruction is received. Reconciliation can be to shipper level, box level, or even right down to individual dose level.
Destruction is always carried out by an approved third party, and certificates of destruction are provided to help you carry out a full reconciliation of your clinical trial supplies.
Since investigator sites often have very limited space for storing study materials, sponsors should know returns may begin to come in before of the end of a study. Prompt and efficient processing of returned study materials is always best accomplished by dedicated returns management staff, otherwise known as people who have the training and skills required for this type of precise and exacting service.
Choosing the Right System
Choosing the right system at the start of a clinical study can have a significant impact on your trial returns process both during and at the end of your study, and at Cryoport Systems, we value your success.
Our Full Clinical Trial Return, Reconciliation and Destruction Services include:
- Certified destruction of hazardous and non-hazardous material through qualified vendors
- Worldwide returned drug accountability and management
- Accountability can be completed at the kit level or down to the unit level
- Temperature-controlled returns (CRT, Refrigerated, Frozen)
- Return kits with materials included for ease of return
- Returns to inventory
- Certificates of destruction
We know that cost-efficiency is crucial when it comes to accounting for clinical drug returns, reconciliation, and destruction. Cryoport Systems is committed to supporting our clients at all stages of the clinical cycle, delivering best-in-class services efficiently and effectively.
Contact us
Contact us to find out how we can help you create a robust returns and reconciliation process for your clinical trial.
