Optimize Phase I Unit Performance and Accelerate Studies

With the sequencing of the human genome complete, the number of new drugs entering Phase I units will increase dramatically over the next ten years. Pharmaceutical organizations must identify, at Phase I, the candidate drugs most likely to succeed and fail to optimize the development pipeline.

The Perceptive Solution

INITIATOR, one of the market's leading products, supports the conduct of Phase I clinical trials from recruitment through to release of study data for report preparation. It is designed to help Clinical Project Managers make earlier decisions in selecting drug candidates for market development. This is achieved by making clean, quality data available much faster than with a manual system. In addition, the system automates many labor-intensive tasks to help conduct studies cost effectively and according to protocol.

INITIATOR has been developed with input from leading sponsors and CROs and recognizes their specific needs when conducting Phase I studies. These are quick set-up, fast and high level of response to late protocol changes, and user friendliness so that unit personnel can administer the system without first hand IT and system support. The product is being used at many small and large Phase I units and has been comprehensively tested in line with the validation requirements of this area.

INITIATOR is an integrated suite of modules.

Reporter - provides instant access to data collected in Operations. The data browser allows for the review, editing and approval of study data. A report generator can be used to produce tailored reports or customizable CRF pages of study data. A configurable exporter provides the means to pass setup information and study data to data analysis, LIMS or other systems.

Preparation - includes flexible study design and amendment, data management set-up, planning and booking of screening appointments, subject time-tabling, activity and staff resourcing, lab analysis requisitioning, sample label preparation and automated eCRF generation. The modules cater for studies requiring multiple treatments, groups and periods. Specific study designs may be created and stored as templates for later use.

Operations - incorporates direct data capture from instruments for all study phases of screening, enrollment, randomization and discharge. The system is user configurable for different modes of operation. Bar coding of sample containers and subjects promotes data quality as the procedures are undertaken. Touchscreen technology allows for data entry with minimal disruption on clinical operations. Once samples are collected they can be tracked through the post collection stages of processing, separation, freezing, dispatch etc.

Laboratory interface - requisitions planned in the Preparation module are dispatched as the samples become available. Samples to be dispatched in any one shipment are logged into a final summary shipment report. As samples are processed at the laboratory, results may be electronically gathered for automatic import into INITIATOR's database, to be reviewed in the Reporter module.

Recruiter - manages volunteer details, study participation, washouts and communications. A comprehensive querying feature allows rapid identification of special populations. Study volunteers may be tracked through the study from initial selection to final follow-up.

Features

• Full 21 CFR part 11 compliance
• Direct data capture from instruments (e.g. blood pressure monitors, ECGs, etc.)
• Real time data access
• Resource optimization, incorporating a range of parameters such as shift patterns, staff skill sets, available / non-available time, etc.
• Use of touch screens for easy data entry in often awkward circumstances
• Technology on a trolley (instruments to bedside)
  Continued bedside operation in the event of network or server failure etc.
• Data export to Data Management systems and other in-house applications
• Strong workflow (what should I do next?) construct throughout the product
• User group solidly supported
• Proven support desk and maintenance approach

Benefits

• Integration with other systems (lab info systems, data management) helps minimize implementation problems.
• Data captured and stored once only means that there is no possibility of transcription errors which might slow down studies.
• Resource optimization gives an ability to handle the maximum number of volunteers at one time, thereby improving trials efficiency.
• Clinical Managers are able to make earlier decisions in selecting candidate drug products for market development.