Chain of custody, captured as events
A laboratory result is usable only when it is definitively associated with the sample, the visit, and the participant. Alethium manages specimen operations end to end, from collection and transport through analysis and storage, and delivers results directly into the participant record.
Lab Selection & Setup
Central and specialty laboratories selected and qualified for the assays a protocol requires, with lab manuals, requisitions, and reference ranges configured before the first sample is drawn.
Kit Management
Collection kits designed, assembled, and shipped to sites and participants, with expiry tracked and resupply triggered automatically before a site runs short.
Specimen Chain of Custody
Every handoff, from collection and courier pickup through lab receipt, aliquot, and storage, is captured as an event tied to the participant record, under temperature-controlled custody appropriate to the sample.
Courier & Transport
Pickups triggered by the visit that produced the sample rather than by a phone call, with time-critical and temperature-sensitive shipments routed accordingly.
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Results Integration
Results flow directly into the study record, reconciled against the expected sample and flagged when they do not match. Values outside protocol thresholds, or any threshold the sponsor defines, trigger investigator alerts immediately rather than at the next data review.
Biobanking & Long-Term Storage
Long-term and cryogenic storage of specimens for future analysis, with inventory, conditions, and consent scope tracked per sample so retained samples are used only as participants agreed.
Safety Lab Oversight
Safety laboratory results monitored against protocol thresholds, with abnormal findings routed to the investigator and captured in the safety record.
Reconciled by Design
Because sample orders, shipments, and results share a single record, no reconciliation is required between laboratory data and study data. A missing result is identified at the point it is due rather than at database lock.
Collected. Tracked. Resulted.
Home collection, central lab, one continuous record.
FAQs - Common Questions
It means laboratory results arrive in the study record already connected to the participant, the visit, and the sample that produced them. Alethium manages lab selection and setup, kit supply, specimen transport, and results delivery, so sites and data managers are not reconciling lab reports against the study by hand.
Yes. Our team qualifies and integrates central and specialty laboratories to the assays a protocol requires, including labs a sponsor has already selected. Lab manuals, requisitions, and reference ranges are configured before first draw.
Yes. Samples can be retained in long-term and cryogenic storage for future analysis, with inventory, storage conditions, and the consent scope governing each sample tracked individually — so retained specimens are only used within what participants agreed to.
Every handoff, from collection and courier pickup through lab receipt, aliquot, and storage, is captured as an event tied to the participant record, with temperature conditions monitored throughout. The custody history and the participant history are the same record, so a sample's full journey is reconstructable at any point.
Results are reconciled against the expected sample on arrival and evaluated against protocol thresholds. Values outside those thresholds, or any custom threshold the sponsor configures, trigger investigator alerts immediately and are captured in the safety record, rather than surfacing at the next scheduled data review. Clinical significance is determined by the investigator.
Because the sample order, the shipment, and the expected result share one record, a missing result is visible the moment it is missing rather than at reconciliation. The gap raises a query immediately and, where the protocol allows, a recollection can be triggered while the participant is still in the visit window.