According to a recent report from Visiongain, the global clinical trial supply and logistics market is estimated to have reached $17.1bn in 2018 – and is predicted to grow to $26bn by 2024.
In response to the evolving market, Almac’s Diagnostic Services business recently launched a sample management service to support client’s biomarker programs. The offering includes pathology review and digital pathology, sample receipt and accessioning, sample storage, as well as downstream processing.
Dr. Leeona Galligan, VP of UK operations, Almac Diagnostic Services, said the service was launched in response to customer demand for vendors that can provide sample management services all ‘under one roof.’ This includes linked clinical trial solutions “to minimize risks and maximize the outcome and data from their clinical trials,” Galligan told us.
Automating chain-of-custody
Almac estimates that automated drug accountability and reconciliation systems can in total save a company a minimum of $1.3m per trial in tangible costs.
According to a report published earlier this year, automation, on average, reduces time spent when reconciling supplies by 87%, or approximately 32 minutes per drug kit. It also cuts the time spent per trial on close-out activities and reports as it pertains to accountability and reconciliation by 35%.
Additionally, because it reduces the number of time monitors spent at clinical sites to complete various activities, the report suggests a further average savings of $435,456 per study.
The main challenges to ensuring effective sample management include inconsistent vendor manifest formats, as Galligan explained, “manifests received in various formats with incomplete mandatory information and a lack of standardization and document quality.”
Samples not labeled as per manifest, not on the imported manifest, or not identifiable also are issues, as is receiving samples in poor condition from clinical sites or other vendors.
Additionally, she said tracing samples from the point of collection to the final destination can also be a challenge.
To address these challenges, Almac’s laboratory information management system (LIMS) and LIMS barcode enables the company to locate samples at any point in time, explained Galligan.
Almac also has partnership agreements in place with a global logistics specialist “to allow the most appropriate courier service for sample collection and delivery,” said Galligan. “These agreements provide access to courier tracking information to ensure a safe, on-time delivery of samples.”