LabPas/CT, the first software to target the critical quality and resource needs of Phase I clinical research, will unveil its significantly enhanced Version 2.5 at the DIA Annual Meeting
LabPas/CT Version 2.5 deploys PDAs on clinic floors to scan patient and collection vessel barcodes, eliminating the potential for errors.
It provides real time electronic data entry for collection times, comments, dosing, vital signs and adverse events.
LabPAS/CT 2.5 also allows integration with document management systems and with biometric systems for positive subject ID.
"The PDA, which sends data to a central database, empowers study staff to scan subject and sample, enter data, etc right at the subject, providing an unprecedented level of accountability," said John Rosenblum, CEO of Green Mountain Logic, developer of LabPas/CT.
"The new features in 2.5 were designed to enhance the unique ability of LabPas/CT to readily adapt to individual study environments and changing protocols, rather than burdening CROs with the need to adapt to the software." LabPas/CT uses a web interface and intuitive navigation and is the most scalable, configurable and customizable workflow and sample management solution on the market today.
Through the innovative use of barcode scanning it eliminates errors, tracks samples, increases throughput, and supports compliance.
In addition, sample collection and dosing are scheduled and tracked according to trial protocols.
LabPas/CT supports compliance with FDA 21 CFR Part 11, GCP and GLP, and also empowers study managers to rapidly alter workflow and schedules as protocols change, by simply dragging and dropping items on their computer screen.
It was developed under Green Mountain Logic's design control process, audited and approved by multiple, nationally-recognised 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.
