Xybion, the makers of Pristima Suite, an industry-leading preclinical data management software solution, announced it will showcase three new modules for FDA SEND, document management and Peer Review at the SOT Meeting and Expo in San Francisco.
Bensalem, P.A., March 8, 2012 /24-7PressRelease/ — Xybion Corporation announced that its Pristima Preclinical Software suite will be featuring several new, preclinical software modules at this year’s SOT (Society of Toxicology) Annual Conference in San Francisco, March 11-15th.
Pristima Suite is an enterprise-class preclinical software and data management solution designed to automate and optimize the end-to-end preclinical drug discovery process. Designed to be used by Pharmaceutical and Biotechnology companies, CRO’s and university research departments, Pristima Suite is a leader in technology and process management for Toxicology and Pathology professionals.
Pristima Suite will be prominently featured at this year’s SOT meeting. The event is an annual meeting for the Society of Toxicology, a global industry association for the advancement of Toxicology as a profession and research practice. Xybion announced the release of three new modules within the Pristima Suite that will be featured at the meeting. The new modules extend the already powerful capabilities of the solution to encompass key processes.
The new Pristima Suite modules to be featured at SOT are listed below and data sheets for each module can be found at https://www.xybion.com/pristima-xd/core
– Pristima for SEND – Standard for Exchange of Non-clinical Data (SEND) is the content standards set by the FDA for the submission of preclinical 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 format 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.
– Pristima DoCs – Built on Microsoft Office, Pristima DoCs is powerful, but easy to use. Formatting and managing comprehensive toxicology data collected by Pristima and other third-party management systems the DoCs module can create final reports which contain narrative sections detailing the study design while importing study protocol fields and numerous data tables directly from the Pristima database. The module will render all of the graphs, tables and statistics functions associated with the data and incorporate these attributes directly into a Microsoft Word Document and protects tables from editing, maintaining GLP data integrity. A template-driven application, Pristima DoCs allows the user to create document templates to standardize the reporting format, permitting the organization to create a consistent, familiar reporting system for contents, appendices, tables and graphs; providing the most rapid and cost effective approach to completing a final report.
– Pristima Peer Review – The module assists participants in the design and development of the peer review plan and facilitates the steps of the entire review process. Flexible, configurable, robust and following peer review best practices, the application allows the laboratory to determine the mode, sampling and timing of the review procedures. To keep the results unbiased and unaltered the primary study pathologist cannot make any further entries or changes to their findings during the peer review process. Once the peer review data entry is completed, reconciliation reports are available. Any differences are reconciled online through the discussion phase and any changes or new findings may be recorded with a reconciliation comment.
Said Carlos Frade, Vice President, Preclinical R&D solutions; “The new modules represent a great advance forward for our customers and prospective clients in the management of data that is key drug in development processes. We continue to expand the platform to stay ahead of the curve with respect to new and valuable technologies to support drug discovery. These new modules reflect our commitment to being the leading provider of preclinical data management software”.
Xybion will be presenting the new modules at its booth and will be hosting a reception for clients, partners and prospective clients at the meeting. You can learn more about these modules at https://www.xybion.com/pristima-xd/core/#core
About Xybion Corporation:
Xybion Corporation is a global leader in the development and delivery of critical enterprise solutions to highly regulated industries. Xybion offers a comprehensive portfolio of interconnected solutions for Preclinical R&D data management, quality/ governance/risk/compliance, Enterprise Asset Management and Enterprise Content/Records Management. Xybion compliments its product portfolio with its Global Development Center, providing broad range of professional services including validation, testing, implementation, project management and custom application development
Xybion provides enterprise solutions for mission critical business processes for highly regulated industries. Xybion supports its global, multi-industry client base with a comprehensive portfolio of interconnected solutions that include:
Quality/governance/risk/compliance Enterprise Asset Management, Enterprise Content & Information Management, Preclinical Data Management
To support Global deployments, our Professional Services include; validation, testing, migration, integration, custom application development, business intelligence, project management, training and global support. Our business partners include: EMC, OpenText, IBM and Microsoft. Our Value Proposition is to lower our client’s Total Cost of Ownership (TCO) for essential business processes, mitigate risks, accelerate growth and maintain regulatory compliance.
609-512-5790 x 316
Head of Quality Assurance
Heidi leads Xybion’s Quality Assurance practice. She has over 20 years’ experience in designing and implementing quality assurance policies. Since joining Xybion in 2000, Heidi worked with several clients to design quality policies and ensure compliance. She is responsible to hosting Xybion customer audits. Heidi has a BA degree in Biology from The King’s College.