March 11, 2016: PointCross Life Sciences and Xybion announced today a strategic partnership to provide the Biopharma industry with a complete suite of data management, standards governance, data quality assurance and regulatory review solutions to comply with the FDA’s mandate requiring submission of CDISC SEND datasets starting in December 2016.
Over the past few months, Xybion and PointCross have collectively found a varied state of awareness and readiness among drug companies and their contract research organizations to meet regulatory review expectations. PointCross, the provider of nonclinical data repository, analytics and viewing tools to the FDA and other clients, is increasingly discovering that the content of SEND submissions routinely fails the litmus test of being trustworthy and “fit for review”, even among companies claiming to be technically SEND ready.
Xybion’s operational expertise and solutions coupled with PointCross’ capabilities offer clients the unique benefit of addressing the entire lifecycle of their nonclinical research and regulatory data management, exploitation and submission needs.
“Biopharma companies need reliable partners with proven experience to give them the security of trustworthy, fit for review data. Likewise, CROs need unique expertise to cope with the enormous change to their processes required for compliance with evolving standards. This partnership will ease the workload of operational data managers, and help both Biopharma scientists and FDA reviewers accelerate drug safety decisions.” said Dr. Suresh Madhavan, CEO of PointCross.
Dr. Pradip Banerjee, CEO at Xybion stated “The need to be SEND compliant by the end of 2016 is currently front and center of all the companies and organizations in the pharmaceutical, Bio-tech and CRO industry. While we are focused on producing SEND compliant datasets for our clients, we recognize that in the broader picture, our clients must be able to ensure that submissions in SEND are also accepted as review-ready by the FDA. Clients can use various approaches to verify that the structure of their data matches the CDISC SEND standard and the FDA’s specifications but ours is the first attempt to provide clients with that next level of assurance based on a reviewer first focus. “
PointCross provides the Life Sciences industry with Big Data analytics, repository, visualization and data assurance services. Our offerings reduce risks, improve data quality, accelerate time to market, and enable better insights across R&D and regulatory data.
The FDA uses PointCross technologies for their SEND viewing, signal detection, validation and repository needs. To learn more, visit www.pointcrosslifesciences.com.
Xybion is the leading provider of software, services and consulting for global corporations operating in highly regulated industries. Our unique solution suite is an end-to-end integrated preclinical lab management, early-stage drug discovery, SEND submission, regulatory compliance and quality management platform.
Xybion's combination of software, business process management, services, validation and staffing enables us to cover a broad spectrum of critical business needs for companies all over the world. Our leadership in this dynamic and ever-changing industry has been a cornerstone of our high-value reputation. To learn more, please visit www.xybion.com