PointCross Life Sciences Opens New Office in Silver Spring, Maryland for Data Standardization of Nonclinical Studies
FOSTER CITY, CA, July 9, 2013 PRNewswire
Extending its recently announced Data Standardization Service, PointCross Life Sciences announced that it has opened a new center in Silver Spring, MD, USA where studies submitted by sponsors to the FDA in PDF and other formats will be standardized to fit into the Agency’s NIMS (Nonclinical Information Management System) environment. Increased access to such structured study data combined with computational review tools in NIMS are aligned with the Agency’s goals of integrating regulatory history into scientific information and advancing regulatory science research.
The PointCross team in the Maryland center applies the same methodology, processes, computational tools and information security controls used by other centers at PointCross Life Sciences. It will focus on standardization of studies already submitted to the FDA.
New studies that require extensions to the NIMS data model to handle novel protocols, innovative studies and new study types will be modeled and provided to the FDA.