Outsourcing
ultiple elements go into designing and carrying out a successful clinical trial; the appropriate participants must be recruited, consent forms processed and regulatory permissions granted. On the supply side, the investigational drug must arrive on time, along with any peripheral equipment. While all these aspects are crucial to ensuring a trial runs as successfully as possible, one critical task that tends to be overlooked is selecting the right clinical laboratory partner. The central laboratory concept was first implemented in the mid 1980s in the US, prior to which most testing was processed by local or
Central intelligence M
Central laboratories have become a crucial part of running global and multi-regional clinical trials. Drug developers place a great deal of trust in these partner organisations, which carry out key processes like testing and specimen management. Sarah Harris asks Christina Hamilton, senior clinical research assistant at Caritas Science Solutions, and Tara Lehner, vice-president of clinical operations at INmune BIO, what they look for in a central laboratory when partnering for clinical trials.
regional laboratories and coordinated by each investigator. Clinical trial sponsors found gathering data from multiple local laboratories that used different testing methodologies, reference ranges and standard operating procedures (SOPs) increased the possibility for errors in the data, method, reagent and reference range changes, leading to lengthened timelines along with increased testing costs.
“Central laboratories play a crucial role in global trials,” says Tara Lehner, vice president of clinical operations at INmune Bio. “They help to standardise results for safety and in certain studies,
Clinical Trials Insight /
www.worldpharmaceuticals.net
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