Mattawan, Mich. – MPI Research announced it has completed the validation of its Instem submit™ software suite, allowing for the creation of consistent, accurate, and high quality datasets compliant with the Standard for Exchange of Nonclinical Data (SEND).
Initially powered by the FDA’s Critical Path Initiative to more efficiently bring medical breakthroughs to market, SEND supports electronic submission of study data to the FDA, enabling faster and higher quality regulatory reviews. In December 2014, the FDA issued the Final Guidance for the electronic submission of preclinical data and in December 2017 SEND will be required for NDA, ANDA, and BLA submissions to the FDA.
“MPI Research is committed to creating comprehensive SEND dataset packages for our Sponsors,” said Dr. Steve Denham, Director of Biostatistics at MPI Research. “Validating our Instem software suite allows us to produce SEND datasets more efficiently. Using the submit™ system allows us to stay up-to-date with the latest versions of the SEND Implementation Guide and cut down on resources that would have been required to maintain an in-house system.”
The submit™ system supports the creation, management, and review of SEND datasets. SEND allows for the efficient exchange of nonclinical data across organizations and provides opportunities for data warehousing and data mining.
“MPI Research has shown real dedication and initiative in leading industry SEND development and implementation efforts,” said Jennifer Feldmann, Vice President of SEND Strategy at Instem. “They have taken the necessary steps to obtain validation months prior to the deadline, which will ensure they can support their Sponsors’ SEND needs now and as future updates occur.”
MPI Research has been an active member of the Clinical Data Interchange Standards Consortium (CDISC) SEND committee since its inception and the company plans to continue leading efforts with CDISC and the Pharmaceutical Users Software Exchange (PhUSE) to help develop SEND best practices.