(Mt. Arlington, N.J., April 21, 2016) — PDS Life Sciences released important news today regarding its SEND Express™ turnkey preclinical data preparation service for FDA submissions.
Based on public comments by FDA representatives speaking at the recent PhUSE 2016 Computational Science Symposium in Silver Spring, Md., PDS has determined that it is the market leader in actual SEND data package submissions to the FDA and has prepared more submitted packages than all its competitors combined.
“With the FDA publicly stating how many submissions packages it has received under its trial program, we were gratified to learn by inference that the majority of those SEND trial submissions were generated with our services,” said Sayed Badrawi, CEO of PDS. “This is important because the market has been filled with noise about SEND ‘experts,’ but in the final analysis what really matters is who can do the work. We have now proven ourselves in that regard.”
To learn more about the FDA’s new data submission requirements, visit http://www.fda.gov/forindustry/datastandards/studydatastandards/default.htm.
PDS also announced that Daniel Potenta has joined the SEND Express business unit as a product manager. He will continue to help build the company’s service infrastructure as demand for SEND services expands.
Potenta joins PDS from Novartis where he spent over 20 years, most recently as manager in research operations responsible for the implementation of SEND compliance for the Novartis preclinical safety group. He is a member of several CDISC and PhUSE working committees on SEND and has been involved with SEND for over 10 years. He holds dual degrees from the University of Dallas and Princeton University.
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, and SEND Express™, your virtual team for FDA SEND submissions, as well as powerful bioinformatics analysis and other services. Learn more at pdslifesciences.com.