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New SEND Submission Requirements Kick in This Year 

You often are asked to provide focused expertise to keep your clients up to date on industry trends and shifting regulatory requirements. One key area in 2016 will be the transition to a new standard for nonclinical data submission: SEND. The FDA is implementing the first phase of requirements for SEND, which will affect how your clients submit data sets beginning December 17, 2016. Now’s the time to ensure your clients stay ahead of the curve in becoming SEND ready.  

You are in a unique situation to prepare your clients for the upcoming requirements and keep their programs on track. Fundamental SEND preparation involves: 
  • Understanding the basic requirements
    To get SEND ready, your clients need: the ability to accept or handle large files, software to view and manipulate SEND datasets, robust storage solutions for warehousing the large files and the ability to submit SEND data sets to the FDA.
  • Enabling cross-functional support 
    Implementing SEND requires a team effort. Your client will need regulatory expertise to understand submission requirements, procurement for vendor and software selection, IT support to validate and implement the software, the collaboration of study teams who produce nonclinical data, as well as scientific subject matter experts.
  • Test-driving the process 
    Building competence in SEND can be facilitated through a test drive in which Covance provides your client with test data files in the SEND format. This allows your client to understand how to open the files, view and analyze the data and conduct trial FDA submissions to confirm acceptance. 
With an experienced partner on their team, your clients can ease into SEND efficiently and form a technical roadmap for their implementation plan. Since 2012, Covance has proactively provided nonclinical submissions in the new SEND format to more than 25 clients with 1,000 studies. Now you can help your client do the same. Helping them prepare for the upcoming requirements will keep their programs on track while streamlining submissions and meeting their development milestones. 

Answers to the Most Common SEND Questions
To help you field questions from clients as they update their FDA submission process and implement SEND, we’ve compiled common questions and answers below.

What is the status for 21 CFR Part 11 compliance of the system(s) producing SEND data sets? 
Any systems used for regulated work are validated in accordance with the 21 CFR Part 11 system requirements. If there are any gaps in the system, they are addressed through a procedural control in order to maintain regulatory compliance. 

What portion of SEND capabilities are automated and/or validated? 
Automation may depend on the software tools in use for data capture and reporting. SEND can be easily automated or partially automated, after which, the automation can be tested and validated. Using an audit trail to track workflow, QC steps are implemented in compliance with SOP directives for documenting QC activities in a partially automated process. 

Can a tool help validate SEND 3.0 data sets before delivering to sponsors?  
Yes, validation tools can be built into SEND data set production software or can be available as companion tools. The validator tool is used to check every data set produced, including interim and draft data sets. This ensures that error notices are resolved prior to providing the data set to the sponsors. Other warnings or notices that cannot be resolved are explained in the define file or accompanying message.
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This issue of Consultant Connection focuses on the new Standard for Exchange of Nonclinical Data (SEND) that will affect your clients’ data sets and FDA submissions beginning December 17, 2016.
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Contact Your Consultant Connector: Michelle Glasgow

As Associate Director of the Client Experience Team, Michelle provides seamless access to any Covance solution. When you need answers and guidance, Michelle is there. Serving as your initial point of contact, she can help you determine your appropriate course of action and connect you with the correct account executive. 
Additional Resources 

Better understand the expectations for SEND and its benefits for smoother FDA submissions with these additional resources: 

SEND Standards & Guidelines

Dig deeper into the specifics of SEND implementation with your clients using these standards and guidelines:  

Let us know if you have questions or would like more information about SEND.