PDS Life Sciences, a global provider of software and solutions for life sciences research and development, was selected to be the preferred provider of research data transformation services for a top-tier global biopharma company. This partnership, which was selected after a competitive evaluation process, will enable the client to effortlessly comply with the newly mandated FDA Standard for Exchange of Nonclinical Data (SEND) requirements without investment in staff or software infrastructure.
The services will be executed by PDS’ dedicated SEND Express™ business unit, utilizing the company’s fully secure U.S.-based data center. SEND Express is a complete outsourced service for the conversion of nonclinical studies to SEND format and includes all the components, such as the Study Data Reviewer’s Guide (SDRG), needed for actual FDA submission. PDS has been responsible for more than half the trial submissions received by the FDA through April 2016.
“Pharma companies, biotechs and CROs are dangerously behind in their SEND compliance preparation. We commend the management team of our client for being proactive in navigating this regulatory submission pitfall,” said Sayed Badrawi, CEO, PDS Life Sciences.
“They have thoroughly assessed their options and selected PDS’ SEND Express team because of our unique turnkey service, high-quality scientific team and guarantee of successful submissions.”
SEND is a new FDA requirement governing the formatting of nonclinical datasets. SEND guidelines were announced in December 2014 with phased compliance going into effect starting December 2016 for certain submission types (NDA, ANDA, certain BLAs). The full set of requirements are effective beginning December 2017, including the formatting of certain IND-enabling studies. Studies started after the required dates and submitted to the FDA in a format other than SEND will not be reviewed by the FDA.
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