Clinical Returns, Accountability and Destruction
At Almac, we can offer clients a greater regulatory focus by providing a complete drug accountability and reconciliation process, based specifically on your protocol requirements, ensuring that clients can remain focused on the drug development process and we will take care of the rest.
Our services include:
If any of our services are of interest please contact our dedicated support team who will be happy to discuss your specific needs and requirements.
Clinical Drug Returns
At Almac our team of clinical supply experts will manage returns and destruction at the end of your trial, or throughout the life of your study reducing the burden and avoiding any backlog at your clinical sites.
During this process we will take into consideration any drug or country specific challenges, co-ordinate all communications between the sponsor or CRO, Interactive Response Technology (IRT) and sites, streamlining trial close out and avoiding any unnecessary costs for the sponsor.
Drug Reconciliation and Accountability
The drug returns, reconciliation and accountability process is often an overlooked aspect of the clinical supply management process and can be complex and time-consuming for the sponsor. With an established process already in place, Almac can provide a dedicated resource support service for product reconciliation and report accountability findings.
We offer two levels for our accountability/reconciliation service:
- Medication Level Accountability
- Drug Level Accountability
Almac can support the destruction of drug product throughout the clinical study as well as at close out from one of our Almac Facilities or via our Global Depot partners. Protocol specific requirements for the frequency and handling of destructions will be agreed up front.
We can reduce the burden and provide support for clinical sites by storing materials until destruction is authorised. The drug lots identified for destruction are packaged onsite into destruction containers, these are then shipped to an offsite incineration company for final destruction with packaging destroyed onsite via recycling or landfill.
Remote Drug Monitoring
Many clinical studies require a monitor to visit the clinical sites which can be very challenging if at all possible. For an active clinical study, it is essential that participating sites are compliant with the dosing and dispensation requirements of a clinical trial.
At Almac, our remote drug monitoring approach can eliminate the need for the Clinical Research Monitor to visit the site and maintains the continued flow of used Clinical Trial Material back to Almac for final disposition. Dosing and dispensation records can be reviewed and compared to IRT assignments remotely to ensure accuracy and completeness of documentation. The service also includes follow-up with site personnel on discrepancies to reconcile material and facilitate the timely return of partially used or expiring material to Almac for destruction.