LabPas CT announced the addition of formulary accountability, recruitment, clinical lab and EDC components to make it the most comprehensive software for the management of Phase 1 clinical studies
"The expanded functionality of LabPas CT is the result of input from our Phase 1 CRO customers".
"We've responded to their desire to automate and integrate every component of their studies to assure the highest level of quality," said John Rosenblum, CEO of Green Mountain Logic, developers of LabPas CT.
LabPas CT deploys PDAs on clinic floors to scan patient and collection vessel barcodes/RFIDs, 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 is also unique in its ability to adapt to individual study environments and changing protocols, rather than burdening CROs with the need to adapt to the software.
Expanded functionality formulary accountability: allows users to track and manage the entire formulary supply chain, including accountability distribution, reconciliation, returns and destruction.
Recruitment: manages volunteer information, including biometrics and clinical results, scheduling and study assignment; allows easy development of study-specific questionnaires; enables searches based on user-defined selection criteria; supports inbound and outbound calling.
Clinical lab: Provides comprehensive study-centric Lims functionality for clinical lab; integrates clinical results into the study database; provides test ranges for test limits, study qualification and clinical alerts; interfaces with standard lab instrumentation.
EDC: easily exports study data in a variety of formats to facilitate the creation of eCRFs.
LabPas CT uses a web interface and intuitive navigation and is the most scalable, configurable and customizable workflow and sample management solution for Phase 1 research on the market today.
Through the innovative use of barcode/RFID 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 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.
