Today’s Challenges: Inconsistent processes and data integrity problems
- Preclinical information resides in numerous internal systems and among several external partners
- Laboratory functions are often covered by a dozen or more software systems, including Protocol Management System, Laboratory Information Management Systems (LIMS), Electronic Laboratory Notebooks (ELNs), Quality Management Systems (QMS), electronic data capture systems, Enterprise Content Management system (ECM), competency management systems, calibration and maintenance management systems and more
- Site Heads, Compound Directors, Study Directors and additional supporting team members and groups lack the necessary transparency of core business data to be able to make clear and informative decisions
- The information required to determine if a compound will become the next innovate medicine or vaccine resides in a variety of knowledge bases and repositories in an organization as well as outside standard/direct information stores
- The process of identifying and developing medicines is long, challenging and resource constraint process. Significant coordination and collaboration of information gathering is required for the process to responsive and successful
- New processes and information stores require validation
- The lack of visibility and insight into real time information results in an inefficient process and inadequate decision support
Transform your entire preclinical R&D process and quality & compliance management
Introducing Pristima® XD – the Xybion Preclinical Gold Standard Digital Laboratory Execution Solution: an end-to-end digital Laboratory Execution System with workflows, innovative technology-driven automation, connected systems and facilities, and data and information management for the entire preclinical process. Pristima XD Total Preclinical Solution provides an end-to-end approach to leveraging new technologies with a tested integration information framework, central data repository, and a standardized archive platform. Xybion has combined several proven industry leading core competencies, to create a Total Preclinical Solutions platform to mirror your overall needs:
- Pristima Core: Preclinical study & data management
- Pristima Operations & Compliance: An Out of the Box validated Business Process Automation solution based on Xybion’s low-code digital cloud platform with built-in GXP Audit, CAPA, Master Schedule management, training and SOP management system and the Content integration, Migration solution platform that provides an intelligent information gateway between disparate systems
- Pristima VM: Complete animal, veterinary, and facility management including IACUC and Census. With compliance-embedded workflows, Xybion’s IACUC Protocol Management Software helps streamline and improve the protocol compliance in adherence to regulations.
- Pristima Savante™: Standard for Exchange of Non-Clinical Data (SEND) and SEND Intelligence Service, Data warehouse with visualization tools like Spotfire
These software solutions combined with Xybion’s Testing and Validation services provides a turn-key implementation unmatched by competition anywhere. You can decrease end-of-study to final SEND submission by 60% with effective data management.
- Provides the foundation to increase preclinical insights.
- Reducing the ongoing effort and cost to execute and validate the processes and technologies with new or existing systems
- Visibility to the information where it resides and initiate actions based on the current business requirements with transparency across the various systems
- A Study Director can readily check on a new compound that is being qualified at multiple sites and automatically initiate a process once a stage gate is reached.
- Initiate workflows and system processes based on events or end users actions
- Real-time information dashboard of Merck’s preclinical pipeline
Retire costly legacy systems and realize the benefits that other Xybion customers are experiencing such as a lower total cost of ownership, more accurate and complete regulatory submissions, and a shorter time to market for new drugs and devices.
CRO Gateway Framework
The Xybion Total Preclinical Solution and Information Integration Framework (PCIIF) provides capabilities to manage, view, tag and manipulate information from multiple repositories/systems.
PCIIF is an integrated BPM and Information Federation platform built by Xybion to support various workflow management and digital content management. This platform can serve as a gateway for process and information integration between Sponsors and CROs.