Implementation
of SEND standard and Data Repository -
PharmQuest assists companies in converting in-house and
CRO generated data to data interchange standards such
as the CDISC SEND standard and in developing data repositories
based on the SEND standard and the related FDA Janus model.
Our experience working with leading pharmaceutical companies
allows us to implement SEND seamlessly within your environment.
There are a number of reasons why an organization needs
to take the SEND standard seriously. If you are a pharma/biotech
company that submits pre-clinical data to the FDA as part
of an IND or NDA submission, then you are the primary
target audience for SEND. The FDA will want to receive
your submission electronically using the SEND format in
the future so that they can expedite their analysis and
approval of your application. CROs will find that their
sponsors are going to be requesting their study data in
SEND format so that they can make electronic submissions
to FDA.
Our experience working with SEND allows us to extend our
best practices and methodologies for SEND Implementation.
Our technology experts give you a thorough analysis and
then successfully implement SEND into your workflow.
