Download supply

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