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The Time Has Come to SEND
Submitting nonclinical data electronically has been possible for some time, but protocols like the Study Data Tabulation Model (SDTM) have always taken a while to become standard. Now, according to this blog by Charles River, the Standard for the Exchange of Nonclinical Data (SEND) will become mandatory for a significant proportion of submissions to the Food and Drug Agency (FDA). Let’s take a look at what that means for CROs in particular.
What is SEND?
Essentially, SEND lays out a format for the submission of nonclinical data. The aim is to standardise data presentation as well as making it easier to submit data and pool information for meta-analysis, based on the protocols and success of SDTM.
SEND was developed in 2002 by a team of vendors and industry leaders in the pharmaceutical and CRO sectors. It has spent some time languishing in the background, mainly due to a lack of early acceptance by the FDA. There was also an issue of user acceptance; as long as the model wasn’t mandatory, many CROs didn’t see the point of investing in the tools needed to implement it. This changed in 2007, when the FDA started to promote the model more and an implementation guide was released (it has been updated several times since). Slowly, SEND has been becoming more of a standard in the last few years.
What’s Happening with SEND Now?
SEND will be mandatory for FDA submissions of single-dose, repeat-dose, and carcinogenicity studies to begin with. This applies whether or not the studies operated under the Good Laboratory Practice (GLP) standard, and the rule will almost certainly expand to other studies shortly afterwards. SEND will be the mandatory format for ANDA (Abbreviated New Drug Application) and NDA (New Drug Application) submissions, as well as Biologics License Applications (BLAs).
This all starts on the 17th of December 2016; any study started on or after that date has to be in SEND format. If you’re looking for more information, this page on the FDA website will help.
What is the Impact on CROs?
As CROs do not have to directly submit study data to the FDA, this may not have a tremendous impact on all of them. However, CROs that can offer SEND-compatible datasets will have an advantage, as they can make life that little bit easier for their clients.
It’s best for any non-SEND ready CROs to bite the bullet and invest in the capabilities that they will need very shortly. As we all know, offering a good service to clients is a multi-faceted goal. In addition to investing in better data with the ActualHCA, you may want to invest in better data formatting with SEND capabilities.