Operate layer · Module 06Physical Ops & Supply
Smart supply & care, in the same audit trail.
The Operate layer of ECS® orchestrates everything that happens around the participant, investigational product delivered where they live, samples returned to the lab, home visits scheduled with qualified nurses, reimbursements paid on time, inside the same platform, on the same audit trail. Inside it sits ISCR, the Interactive Supply Chain Response engine: the smart core that forecasts demand, triggers resupply and keeps allocation, logistics and adaptive protocol changes in sync.
Two rails around the participant. One audit trail.
Investigational product moves outbound (D-T-P). Samples, devices and used kits return inbound (D-F-P). Both share the same identity, consent and audit trail.
GDP-qualified, temperature-controlled.
Cold-chain lane, chain-of-custody signatures.
Delivered where they live, opened in LucaH®.
Sample, used kit or device, packed with LucaH®.
Return lane, temperature and time monitored.
Reconciliation & accountability records closed.
Interactive Supply Chain Response (ISCR)
Purpose-built responders that keep the physical study in lock-step with the digital record, from randomisation, through IP administration, through sample logistics.
Interactive response system for computerised IP-to-subject random assignment, with multi-parametric stratification and allocation logic, set once, versioned throughout.
Pairs Subject_ID with Random_IP at point of dispense. Monitors IP delivery and surfaces non-adherence risk through visual data collection and live compliance checks.
Pairs sample kits with Subject_ID and connects directly to certified couriers for sample delivery and recollection between home and lab, with chain-of-custody closed end-to-end.
Purpose-built, module by module.
Investigational product shipped direct-to-participant, temperature-controlled where required, with chain-of-custody signatures captured in-app.
Samples, devices and used kits picked up from where the participant lives and routed to the lab, depot or destruction, closed inside the same workflow.
Return of used vials, unused kits and devices, with reconciliation flows that close the loop for accountability and destruction records.
Qualified nurses scheduled, briefed and dispatched to the participant's home for phlebotomy, dosing, and protocol-defined procedures.
Travel, time and expenses reimbursed transparently, on time, with tax-compliant flows across jurisdictions.
Qualified couriers, GDP-compliant lanes, and full traceability from depot to participant and back, visible to sponsor, site, and monitor in real time.
ISCR projects consumption per site and participant, sets reorder thresholds, flags expiry windows and minimises IP waste, resupply triggered by signal, not by spreadsheet.
Randomisation, kit assignment and drug-supply forecasting run inside ECS®, so allocation, resupply and D-T-P shipping share one source of truth.
Sites, home-nursing vendors and logistics partners work inside the same workflow, no email triangulation, no spreadsheet reconciliation.
Regulatory & standards frame.
The regulatory and standards backdrop this module is designed against.
Qualified lanes, temperature control, chain-of-custody signatures depot-to-door.
Compliant packaging and monitoring for temperature-sensitive IP and biological samples.
Investigator oversight preserved for home visits and mobile procedures.
Operational quality-by-design, risks logged, mitigations tracked.
Participant payments handled across jurisdictions with local tax rules.
Serialised chain-of-custody from depot to participant and back for destruction records.
Built to be handed to a regulator, with regional data residency in the sponsor's jurisdiction.
The rest of ECS®.
Describe the logistics the protocol needs.
Cold chain, home nursing, direct-to-participant supply or pharmacy touchpoints. We scope the physical layer against your countries.