Cedar Knolls, NJ (PRWEB) November 11, 2011
The Xybion Corporation announced today the release of Pristima Version 6.3, which includes Pristima® SEND, a data exchange mechanism for generating submissions compliant with the FDA’s SEND standards. Pristima SEND is part of the Pristima Suite, the industry’s leading end-to-end software platform for pre-clinical R&D data and process management. Available as part of the Pristima Suite or as a stand-alone data exchange vehicle for other systems, Pristima SEND provides clients with a method to generate SEND compliant submissions to the FDA and communicate study information between CROs and sponsors.
The FDA recently ratified the Standard for Exchange of Non-clinical Data (SEND) for the submission of pre-clinical safety assessment data. By creating recognized standards for the submission of pre-clinical data, SEND facilitates communication between research organizations, sponsors and regulators. As an Associate Member of CDISC™ (Clinical Data Interchange Standards Consortium), the advisory committee to the FDA for the SEND initiative, Xybion has developed an acute understanding of the requirements and best practices. The Pristima® SEND conduit is fully integrated into the Pristima® Data Management Suite and is designed to comply with the FDA regulatory criteria. Acting as a channel to concentrate and format the preclinical data, Pristima® SEND 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. Pristima SEND leverages and aggregates the client’s existing data, even if the client does not utilize Pristima as its primary data management system.
Working in close cooperation with clients to identify value added capabilities, Xybion has developed the Pristima SEND conduit with a transfer mechanism to facilitate the exchange of data between the CRO and the sponsor. Pristima has the unique capability of producing the output in an untransformed manner allowing CRO’s to provide their clients with the data normalized to a SEND compliant format or provide clients with the data in its raw state, better serving the sponsor’s needs for a data warehouse. Pristima can produce SEND compliant datasets in XPT, XML, CSV output formats. By including a mechanism to translate terminologies from the client’s source database into the SEND controlled terminology, Pristima is uniquely positioned to serve our client community’s immediate need as well as to facilitate the FDA’s submission process for the entire industry.
As with the entire Prisitma Suite, Pristima SEND can be installed onsite or hosted remotely. Clients are able to upload data from third-party data sources and generate a compliant dataset to exchange information between the sponsor and FDA as well as the sponsor and the CRO performing the study.
“This is an important milestone for Xybion, in our continuous efforts to address the market’s demands, we have developed a solution for our clients to communicate effectively and meet the requirements of the SEND initiatives”, explained, Dr. Pradip Banerjee, CEO for the Xybion Corporation. “With our ongoing improvements and innovations, Pristima continues to be at the forefront of the preclinical market.”
About Xybion Corporation:
Xybion Corporation is a global leader in the development and delivery of critical enterprise solutions to highly regulated industries, helping companies lower cost, mitigate risk and accelerate growth, while managing quality and compliance. Xybion offers a comprehensive portfolio of interconnected solutions for quality/ governance/risk/compliance, Preclinical R&D data management, Enterprise Asset Management and Enterprise Content/Records Management for clients across multiple industry sectors. Xybion compliments its product portfolio with its Global Development Center, providing broad range of professional services including validation, testing, implementation, custom application development, business intelligence, project management, training and global support. Xybion’s products and services are designed to help organizations achieve higher levels of performance, efficiency, compliance and sustained corporate governance.