WebEZ™ An Innovative Solution to the Drug Supply ... - Almac

WebEZAn Innovative Solution tothe Drug SupplyManagement ChallengeDonna Christopher, R.Ph.Vice President of OperationsClinical Trial Services (US), Inc.

Pharmaceutical Care“Making sure you have the right drug, in the rightplace, at the right time”•Sites don’t have too much drug.•Sites don’t have too little drug.•Sites have the right type of kit available.

The Challenge• How do you effectively manage the drug supplywhen you don’t have control of the distributionprocess?• How do you effectively manage the drug supplyfor projects where there is no automatedmethod of randomization?

Key Objectives for the Solution• System must interface directly with ourinternal drug supply management system.• Must assist PM’s in providing complete drugsupply management services.• Must assist the PM in being able to documentthe complete life cycle of each drug kit(packaged ⇒shipped ⇒assigned to apatient⇒returned for destruction).

Key Objectives for the Solution• PM’s must be able to set up projects andperform project maintenance with little or noIT support.• Solution must be Part 11 compliant.• Solution must be very user friendly. As easyas getting cash from an ATM.• Must be able to get projects up and runningquickly.

Drug Supply Management ChallengeBulkDestroyedFinishedReturnedShip

The Solution• Drug Supply Management (DSM) System• Project Management, Inventory, Assembly,Distribution• WebEZ– Web-based enrollment application linked tothe DSM System– Used by Clients and Sites• WebRand– Used by CTS Project Staff

WebRand Functionality• Protocol set-up• Generation of randomization schemes• Generation of kit lists• Protocol maintenance• System administration• Create/modify accounts, set security privileges

WebEZ Functionality - Sites• Screen, enroll or randomize patients• Discontinue patients• Unblind treatment• Order ancillary supplies• Assign “resupply” kits to patients• Reports• Message Board• View study documents

WebEZ Functionality - Clients• Activate sites for enrollment and initial drugshipments• Unblind treatment• Order ancillary supplies• Reports• Message Board/View study documents

WebEZ Timelines• After specifications are approved, validatedsystem available within days.• Product will be released Nov 2004

Target WebEZ Trials• 80 pts, 10 sites, 4 arms, 1:1:1:1 randomization• 250 pts, 15 sites, enrollment only• 150 pts, 20 sites, 2 arms, 2:1 randomization• 40 pts, 5 sites, 4 dosing cohorts