Xybion Preclinical LIMS software, Pristima, is an end to end preclinical management of In vivo study management (Toxicology, Safety Pharmacology, PK, PK PD, Immuno Safety, Disease Modeling) and management of regulatory submissions such as SEND dataset. This system helps manage study planning, costing, inlife and postlife processes, data, quality & compliance and submissions. Pristima is the only commercially off the shelf available system, which can fully integrate all preclinical LIMS and data management areas with a single product that is built with modern, robust tools, allows full compliance with 21 CFR Part 11, that can meet regulatory needs out of the box. The integration of all activities into a single system promotes effective metadata-based data interchange between laboratory departments, reduces staff training, system support costs, and streamlines reporting activities, all of which shorten the time from study initiation to final reporting, hence reducing the drug research timeline. It reduces the overall cost of conducting a study.

Pristima capabilities

Pristima Core offers Preclinical Research study, data management, statistics, analytics and reporting. This module will support Toxicology, Safety Pharmacology, PK, PK PD, Immunosafety, Disease modeling workflows

Pristima Savante is a Data warehouse with visualization tools like Spotfire. This enables Standard for Exchange of Non Clinical Data (SEND) and SEND Intelligence Service.

Pristima Vet Management (VM) provides unsurpassed management capabilities for Animal Care and Use Committees, veterinary health, orders, billing, and clinical records, IACUC Protocols and Census for long term studies.

Pristima Operations and Compliance (O&C) is an out of the box validated Business Process Automation solution for Quality Management such as Master Schedule management, GXP Audit, CAPA, Deviation, Change Control, Document management, Competency Management and the Content integration, Migration solution platform that provides an intelligent information gateway between disparate systems. This replaces the need for a separate QMS system for auditing research work.

Pristima Core

Security (organization structure, people)

Facility Management (Equipment, Location, Supplier)

Lexicon Management (Clinical Observation)

Animal Management (Supplier, Species, Strain)

Animal Room and associated reports and Study Toolbox

Colony Management Module

Pathology

Necropsy

Histology

Relevant Finding (RFM) module

Clinical Pathology Analysis

Pharmacy and Inventory

Protocol Management

Instrument Integration

Instrument Calibration

People Competency Management

Reports and Dashboards

Pristima Vet

Vivarium Management with Rack mapping

Animal Ordering & Management

Accounting with Invoicing

Regulatory Management

Facility Management

People Management

Supporting RFID, Barcoding systems

Pristima Savante

Data warehouse for non-clinical Labs. Integrated SAS, XML, CSV formats. SDTM Domain, Sub-Domain visualization, SENDIG 3.1.1

Pristima Operations and Compliance

Study Registry

Report Management

Quality Management: Audit, CAPA, NC, Complaints, Master Schedule

Document Management

Compliance for Lab Research Admin

Complaints Management

Competency Management