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By law, the FDA will be expecting all nonclinical data for studies submitted to support a regulatory submission to be in a SEND format.
The regulation is part of part of the US Prescription Drug User Fee Act (PDUFA V). Once the regulatory deadline is passed, ALL relevant nonclinical studies must be collected electronically in SEND format.

Is your laboratory ready?

SEND” is the Standard for the Exchange of Nonclinical Data, which is an CDISC (Clinical Data Interchange Standards Consortium) standard representation of datasets and terminologies to simplify data sharing and enable tools for analytics, search and visualization.
What does SEND do?
  • Provides a standardized presentation of toxicology study data in an electronic format
  • Enables the development and use of visualization and analytical tools for these types of data
  • Enables more effective and efficient review of nonclinical toxicology data.
As part of PDUFA V, the FDA will require nonclinical study data to be submitted in the SEND format.

The PDUFA V Agreement Letter states that this will IMPROVE THE EFFICIENCY OF HUMAN DRUG REVIEW THROUGH REQUIRED ELECTRONIC SUBMISSIONS AND STANDARDIZATION OF ELECTRONIC DRUG APPLICATION DATA.

The requirements for electronic submission shall be phased in according to the following schedule:
Timing                        Phase
Start Publication of the final guidance
24 months after publication of the final guidance All new original NDA and BLA submissions, all new NDA and BLA efficacy supplements and amendments, all new NDA and BLA labeling supplements and amendments, all new manufacturing supplements and amendments, and all other new NDA submissions.
36 months after publication of the final guidance All original commercial INDs and amendments, except for submissions described in section 561 of the Federal Food, Drug, and Cosmetic Act.
Periodically FDA shall periodically publish final guidance specifying the completed data standards, formats, and terminologies that sponsors must use to submit data in applications. In the case of standards for study data, new data standards and terminology shall be applicable prospectively and only required for studies that begin 12 months after issuance of FDA's final guidance on the applicable data standards and terminology

Robin Guy Consulting will work with your company, consortia, laboratory and your preferred contract research organization (CROs) for SEND training. We work with you to help you understand what SEND is all about and how it will affect your business. There is a steep learning curve for SEND, and it takes time to get ready.

FDA’s CDER is ready and has already been accepting SEND datasets. Currently, the FDA is determining the nonclinical data standards requirements for the Center for Biologics Evaluation and Research, Center for Devices and Radiological Health, and Center for Food Safety and Applied Nutrition.

In addition, note that manually collected data will need to follow the recognized standard lexicon for submitted data for SEND purposes. Robin Guy Consulting can help your laboratory personnel get trained on SEND and STDM terminology, in addition to appropriate Standard Operating Procedure (SOP) preparation.


Datasets in SEND format can easily have up to hundreds of thousands of data points. As in the past, the Sponsor is legally responsible for the content of data provided to the FDA.  The Study Director is legally responsible for the accuracy of the data from their studies. It will be critical for your company to have a Quality Assurance data audit on these sets of data.

Robin Guy Consulting will provide third party, GLP audits of SEND data for laboratories, both Sponsor and CRO laboratories.


After a certain point, studies conducted to support INDs or NDAs will need data recorded electronically with software capable of converting to CDISC standard format for the FDA and Company internal management or data mining/analytics needs.  The FDA will be reading your data via their Nonclinical Information Management System (NIMS). SEND-ready software will be a critical requirement at this point.

Some companies may not have the resources to collect data manually, or may have non-SEND data. However, since the FDA will require data be entered into SEND-ready electronic formatted software, data will have to be transcribed into the SEND standard format electronically. Robin Guy Consulting also provides this service.

Word of advice: Even manually collected data will need to follow the standardized lexicon published for SEND purposes. Robin Guy Consulting can help your lab get prepared for this, including training and Standard Operating Procedure (SOP) preparation.

Your laboratory may also desire to purchase validated software to ensure SEND compliance.  Robin Guy Consulting also works as a liaison with your company and SEND software providers to assist you in obtaining the proper SEND data collection software for your laboratory. 

 
   
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