Phase 1 Clinical Trial Data Management Streamlined by New GML Software

Highly adaptable and robust, LabPAS/CT™ targets the critical quality and resource needs of Phase I clinical research. This remarkably agile software solution uses innovative barcode scanning of subjects and samples to eliminate errors, track samples, increase throughput, and support compliance. In addition, sample collection and dosing are scheduled and tracked according to trial protocols.

 

“Consulting with CROs conducting Phase I clinical trials, we discovered their desperate need for a system to meet rigorous quality demands in a rapidly changing regulated environment,” said Green Mountain Logic CEO John Rosenblum.  “LabPAS/CT not only supports compliance with FDA 21 CFR Part 11, GCP and GLP, but also empowers study managers to rapidly alter workflow and schedules as protocols change, by simply dragging and dropping items on their computer screen.”

 

Using a web interface and intuitive navigation, LabPAS/CT adapts to individual CRO lab environments, instead of the other way around.  It is the most scalable, configurable and customizable workflow and sample management solution on the market today.

 

“Initial users report that LabPAS/CT shortens study setup time, eliminates errors, and provides unprecedented accountability,” said Rosenblum.   “Equally as important, study managers are delighted with its rapid installation and easy configuration.”

 

LabPAS/CT was developed under Green Mountain Logic’s design control process, audited and approved by multiple, nationally-recognized pharmaceutical clients. GML is in compliance with FDA guidance for the development of high-risk software systems and for development of Class 2 Medical Devices. 

 

Green Mountain Logic provides pharmaceutical companies and contract research organizations with automated workflow solutions that enhance drug development by improving sample quality, increasing productivity, and speeding throughput.

 

Contact: Pat Sears

Green Mountain Logic, 7 Court Street, Montpelier, VT 05602

1.866.LabPAS1     info@gmlogic.com      www.labpas.com