Clinical Trial Returns: Return to Sender is an article courtesy of ICT (International Clinical Trials) that focusses on the later logistics of clinical trial returns management
Trial planning inevitably focuses on the set-up and timely delivery of studies – and less on later logistics such as clinical trial returns and the return of unused drugs. But neglecting this issue can lead to scope creep and unexpected costs, which is why early dialogue and decisions on returns are essential.
In recent years, the pharmaceutical industry has witnessed tremendous change in the way it is expected to deliver new drugs to market. This has been driven by several factors.
The industry has faced head-on the prospect of ‘the patent cliff’, losing about $290 billion in revenue from branded prescription medications going off-patent. At the same time,drug development timelines are under constant attack, with speed to market paramount to success. As such, innovation and cost-effi ciency is crucial.
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More about our Our Clinical trial Returns Management
In-keeping with client requirements, we can arrange for the return, storage and ultimate destruction of clinical trials materials at the end of a project. Returns can be reconciled to one of three levels before being securely stored until the approval for destruction is received:
- Level 1 – reconciliation of the number of shippers returned only
- Level 2 – reconciliation of the contents of the shippers against a packing list
- Level 3 – full reconciliation down to individual tablets, capsules, and vials
Destruction is carried out by an approved third party including witnessed destruction for controlled drugs. Certificates of Destruction are provided to clients to facilitate full reconciliation of clinical trial supplies.
As well as Clinical Trial Returns we provide complete Clinical Trial services
PCI is committed to supporting clients at every stage of the of the clinical cycle, delivering best-in-class services efficiently and effectively. Our clients come to us seeking solutions to often complex and unique opportunities due to our reputation in offering unmatched flexibility, a client-centric experience and consultative approach.