MT. ARLINGTON, N.J.--(BUSINESS WIRE)--PDS Life Sciences, a leading global provider of intuitive data management software and solutions for life sciences research, helped a major pharmaceutical company become one of the first to successfully submit a Biologics License Application (BLA) that incorporated the FDA’s new Standard for Exchange of Nonclinical Data (SEND).
“This project confirms our ability to do just that and demonstrates the leadership and support PDS will uphold as the industry makes the transition to SEND compliance.”
The company approached PDS because of the project’s complexity, needing to convert and prepare non-standardized data from numerous heterogeneous studies for submission quickly. PDS provided complete submission management services, including the composition of a Study Data Reviewer’s Guide. As a result, the FDA accepted the entire data package.
“Other solution providers may tout their SEND clients,” said Sayed Badrawi, CEO of PDS, “but PDS is the first to publicly advise a successful submission of a new drug application to the FDA that adhered to SEND requirements.”
The FDA has issued final guidance on standardized electronic data. Data for studies starting after Dec. 17, 2016, supporting applicable NDAs, BLAs and ANDAs, and studies starting after Dec. 17, 2017, supporting IND submissions, must be submitted in SEND format.
“Our goal is to make SEND implementation a benefit to our clients, not another hurdle,” said Badrawi. “This project confirms our ability to do just that and demonstrates the leadership and support PDS will uphold as the industry makes the transition to SEND compliance.”
PDS is also the industry’s first provider to make an FDA-validated, preclinical research SEND dataset publicly available free of charge and qualification. To learn more about PDS’ SEND services, including TranSEND™, the complete submission management solution, visit Booth 1634 at the Society of Toxicology 2015 Annual Meeting and ToxExpo™, or visit pdslifesciences.com.
About PDS
For more than 30 years, PDS has provided intuitive data management software and solutions for life sciences research and development programs worldwide. Most of the world’s top 10 pharma companies rely on PDS software, as do industry-leading CROs, chemical companies, universities and regulatory agencies. The PDS software lineup is centered on Ascentos™, your integrated preclinical software solution, which is purpose-built to support toxicology, clinical pathology, reproductive toxicology and anatomic pathology. PDS also offers TranSEND™, your complete FDA submission management solution, as well as powerful bioinformatics analysis and other services. Learn more at pdslifesciences.com.
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