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Transcript
supply IDDI Clinical Trial Drug Supply Management System ID-supply is a real time workflow management system for clinical drug supplies that allows efficient drug distribution to clinical sites. The real time status of medication stock levels allows for the automatic issuing of supply shipment orders to the sites. TM ID-supply operates seamlessly in conjunction with ID-net , IDDI’s centralized randomization web systems and any connected system. TM TM ID-supply provides automatic management and reporting for the complete cycle of the drug supply process. TM ID-supply allows complete follow-up of the treatment kit life, from manufacturing to patient administration including quarantine management, tracking of damage kits, temperature excursion or end of shelf life. TM IMPLEMENTATION WORKFLOW The randomization list of medication kit numbers may be issued and provided to the drug packaging unit. The medication supply strategy is defined in collaboration with the sponsor, based on delivery times and production restrictions. Initial supply orders are issued when the site is initiated, at first patient registration or on specific events. The center receives shipment and confirms receipt of medication kits using ID-net TM and reports damaged kits. ID-supply The center allocates medication kits to patients. When site stock level reaches the pre-defined threshold, an order is automatically issued and sent to the distribution center to re-supply the site in time. This order will address medication needs for new patients and patient re-supply. The monitor performs medication accountancy and reconciliation with the drug dispense log and controls the return of the drug for destruction. TM IDDI CLINICAL TRIAL DRUG SUPPLY MANAGEMENT SYSTEM ADDING VALUE TO CLINICAL DATA KEY FEATURES Total automation of clinical drug supply shipment and on-site management Multi-stage treatment allocation Multilevel stock management: integration of central and local depots, local distributors and pool of centers, pool of medication Double-blind and open-label products Online real-time reports (stock, kits, status, orders…) Status reports automated by fax/email/web interface Implemented in conjunction with ID-net Relabeling Randomized kit list Ad-hoc features to support specific drug accountability and reconciliation Study drug expiry management and retest dates TM BENEFITS Reduced wastage Re-supply process based on actual subject accrual and treatments, logistics, import license, time constraints … Dose adjustment according to treatment schedule or patients characteristics Optimized medication usage and shipment Real time monitoring of medication stock using reports, trackers and alerts Just-in-time supply Flexible solutions to support adaptive designs Multiple drug supply strategies AVAILABILITY COMPLIANCE System 24/7 availability Toll free help lines Help from qualified IDDI personnel Attendance to investigators meeting, web training Fully validated 21 CFR part 11 compliant system Direct electronic interface with supply packaging and distribution providers SECURITY Secured access only to authorized users SSL 3.0 and data encryption at 128 bits from the server Secure servers with on-site and off-site backup Events history stored in a audit trail MORE INFO? www.iddi.com [email protected] EUROPE USA 30, Avenue Provinciale B-1340 Louvain-la-Neuve Tel : +32 10 61 44 44 Fax : +32 10 61 88 88 363 N. Sam Houston Pkwy. East, Suite 1100 Houston, TX 77060 Tel. 1 281 820-7850 Fax 1 281 820-9310