Sample and Supplies Management

Sample Management

Sample Management from a Central lab perspective is when a trial or a study has a single lab entity to manage the handling of samples. Starting with post collection and storage (if applicable) at site, to ensuring appropriate sample traceability during pre-analytical, analytical and post analytical workflows at the lab including aliquoting under aseptic conditions and biorepository, and also logistics tracking for the onward dispatch of the samples either to global labs for highly esoteric testing or return to sponsor. Sample identification and Barcoding, maintaining of SOPs and workflows as well as efficient record keeping form an essential part of sample management overall Dr Dangs Lab is well versed in all that is required to provide effective sample management across various studies.

For appropriate sample management, the following play a critical role:

• Quality based sample collection and storage if required at site: Dr Dangs Lab helps with providing QA approved manuals, physical or remote training, sample identification criteria ensuring two sample identifiers and manifests for sample shipments
• Customized TRFs with bar codes approved by sponsor
• Accessioning at lab with QC checks of each TRF as well as subsequent QA audits
• Sample segregation and aliquoting done under aseptic conditions
• Biorepository storage and retrieval

Logs maintained include:

• Aliquot tracking and reconciliation sheet _ for tracking of the number of aliquots used from the batch.
• Aliquot detail for clinical study of sample _ to enlist the number of aliquots made from a received sample

Supplies Management

Provision of Global standard supplies for sample collection is a critical step in the maintaining of pre analytical quality ensuring best of results. The following play an important role, with Dr Dangs Lab having delivered on the same efficiently across several studies:

• Kit building by a Dedicated Dr Dangs Lab kit building team Only global standard material included within kits Specialised Urine containers allowing for preservation of urine routine samples used Pipettes and cryovials included in case aliquoting at site is desired Individual kits per subject labelled with expiry date, study name, visit and any other information as requested by the sponsor Kit labelled overall with expiry of the item within it carrying the shortest expiry time Kits accompanied by ancillary supply and Despatch form Providing of replacement kits
• Prior information provided for Last call time and pick up time
• Individual site coordination by Program Managers
• Temperature controlled shipments in association with qualified vendors

Additional Key Practices

• Prior information on last call and pickup time
• Individual site coordination by Program Managers
• Temperature-controlled shipments via qualified vendors