Products & Services
Preclinical Lab Managment
The Pristima Suite™ is the FIRST fully integrated end-to-end enterprise solution for tracking and managing veterinary facilities and research subjects throughout the preclinical research process. From breeding and ordering through the study submission process, the Pristima software platform delivers essential capabilities across the entire drug discovery process to facilitate your entire research program. For over 25 years, global pharma companies and CROs have relied on our flagship Pristima preclinical data management suite for effective, end-to-end processes. Pristima delivers quality, efficiency, and compliance assurance.Our Unique Advantages
- Integration By Design. The Pristima Suite is designed as a fully integrated pre-clinical data management system. The modular design of Pristima ensures seamless interoperability throughout the full preclinical lifecycle process for greater efficiency and minimal expensive customization.
- SaaS License Option Available. The power of the Pristima suite is now available in a hosted environment through a Software-as-a-Service licensing model.
- Multi-language Support. Pristima supports all western and Asian character sets and thus supports a wide variety of languages such as English, Chinese, French, German, etc....
- Streamlines Reporting & Submission Processes. Pristima helps streamline reporting and submission processes through the delivery of real-time statistical analysis.
- Ensures Data Quality Management. Pristima promotes quality data management at all times through business rules, security and audit trails.
- Unlimited Number of Simultaneous Studies. Pristima supports an unlimited number of simultaneous studies and users.
- Integrated with Quality Management. Because Xybion provides both preclinical AND quality management solutions, we can easily integrate the Pristima Suite with our enteprise quality management solution, eQCM to ensure you preclinical systems work with your quality and compliance initiatives.
The Pristima Suite is a comprehensive Research and Safety Study Management application.+ Read More
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- An integrated approach to GLP
- Xybion has been an industry leader in providing technology and services that support a number of sub-categories for GxP including cGLP, cGMP and cGCP for over 30 years. Our technology, software and validation services are used by 70% of the top 20 Life Science companies. Being subject to an every changing environment of government regulations which require certain Best Practices to be followed, LifeScience companies face unique challenges that detract them from their core business. Xybion is your partner in that we alleviate many issues of GxP and help reduce technology costs designed to support GxP with our integrated approach.
- Why we are different?
- Xybion is truly unique amongst software vendors who typically support GLP as discrete, departmental function. We provide a broad framework of technology, with underlying BPM designed to facilitate the rapid deployment and customization of a total compliance framework. Our combined Compliance and Preclinical solutions help companies ensure GLP adherence at the root level.
- How we support GLP?
- A typical example of what must be followed for the pharmaceutical industry is as follows:
- For a drug to be produced in a GxP compliant manner, some specific information technology practices must be followed. Computer systems involved in the development, manufacture and sale of regulated product must meet certain requirements.
- The pharmaceutical industry therefore must by law heed various things:
- Secure logging: each system activity must be registered, in particular what users of the system do, that relate to research, development and manufacturing. The logged information has to be secured appropriately so that it cannot be changed once logged, not even by an administrative user of the system.
- Auditing: an IT system must be able to provide conclusive evidence in litigation cases, to reconstruct the decisions and potential mistakes that were made in developing or manufacturing a medical device, drug or other regulated product.
- Keeping archives: relevant audit information must be kept for a set period. In certain countries, archives must be kept for several decades. Archived information is still subject to the same requirements, but its only purpose is to provided trusted evidence in litigation cases.
- Accountability: Every piece of audited information must have a known author who has signed into the system using an electronic signature. No actions are performed by anonymous individuals.
- Non-repudiation: audit information must be logged in a way that no user could say that the information is invalid, e.g. saying that someone could have tampered with the information. One way of assuring this is the use of digital signatures.
- Stringent record-keeping requirements and traceability: It is necessary to create and to document a chain of decisions that lead from user needs and business goals down to the system design decisions, and the verification of proper system installation and operation.
- Litigation and Regulation Support: Persons bringing lawsuits, and regulators, can subpoena or otherwise demand to obtain certain information which must be available and which must have been maintained according to law. This information must be promptly furnished to them in the format they require. The industry must be able to satisfy such requests promptly at any reasonable time.
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Pristima Suite®, the Total Preclinical Lab Management Solution, provides a module to facilitate the FDA SEND standards for preclinical submissions. The Standard for Exchange of Non-Clinical Data (SEND) is an implementation of the Study Data Tabulation Model for non-clinical studies. This standard was developed by the Clinical Data Interchange Standards Consortium’s (CDISC) SEND Team for non-clinical data collected from animal toxicology studies is the FIRST fully integrated end-to-end enterprise solution for tracking and managing veterinary facilities and research subjects throughout the pre-clinical research process. From breeding and ordering through the study submission process, the Pristima Suite™ delivers essential capabilities across the entire drug discovery process to facilitate your entire research program. For over 25 years, global pharma companies and CROs have relied on our flagship Pristima pre-clinical data management suite for effective, end-to-end processes. Pristima delivers quality, efficiency, and compliance assurance. Click here to view CDR SEND Pilot information on the FDA Website.Standard for Exchange of Non-clinical Data (SEND) is the content standards set by the FDA for the submission of pre-clinical safety assessment data. By creating a recognized standard for submission data, SEND facilitates communication between research organizations, sponsors and regulators. The Pristima® SEND Conduit (SCC) is fully integrated with the full Pristima® Data Management Suite is designed to comply with the FDA regulatory guidelines and standards. Acting as a channel to concentrate and reformat preclinical data, the Pristima® SCC module is designed to support SEND compliant data submissions to the FDA from a variety of data sources, including Pristima®, Xybion’s legacy PATH/TOX SYSTEM and other third party data management systems such as those used for toxicokinetic data management. Xybion designed the SCC module to rigidly adhere to the current CDISC standards. As an Associate Member of CDISC™ (Clinical Data Interchange Standards Consortium) Xybion has a thorough understanding of the requirements and best practices. Additionally, working in close cooperation with a large CRO client to identify value add capabilities, Xybion has developed the SCC module with a transfer mechanism to facilitate the exchange of data between the CRO and the sponsor. The Pristima® and PATH/TOX SYSTEM customer benefit from a seamless integration of these application suites and a friendly user interface that provides the user with guides and queues to complete the submission.
The Pristima Suite is a comprehensive Research and Safety Study Management application. The system offers advanced capabilities for toxicology and pathology data management. Pristima® VM delivers extensive capabilities for Vivarium Management and Veterinary Care. This unique solution delivers key features that effectively bridge the gap between the business, animal management and scientific aspects of research absent in many of today’s pre-clinical solutions. Pristima® VM’s rich graphical user interface and detailed reports and visualizations deliver the most comprehensive animal facility solution.
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