Is Your Team SEND-Ready?

The Standard for the Exchange of Nonclinical Data is a new set of regulations that guide the submission of nonclinical data in a consistent digital format to the FDA. In December 2014, the FDA CDER and CBER divisions released industry guidance enforcing the full adoption of SEND by NDA, ANDA and BLA studies that start on or after Dec. 18, 2016, while SEND became required for INDs starting Dec. 18, 2017. This mandate will requires these study submissions are compliant with the new SEND format requirement or risk FDA rejection.

SEND Overview:

• SEND is the reorganization of nonclinical data into a standardized digital data format that clearly outlines metrics taken during the studies as well as their results. Without the proper knowledge and tools, SEND submissions may take months to properly prepare and format.
• Major SEND components
  • Define.xml
  • Define.pdf
  • Study Data Reviewer's Guide (SDRG)
  • Validation reports
  • Terminology mapping
  • XML domain files
  • Laboratory (LB)
  • Macroscopic findings (MA)
  • Microscopic findings (MI)
  • Etc.

SEND Implementation

SEND has major implications for drug development:

• Noncompliance will result in a refusal to file from the FDA resulting in submission delays; these formats are used by the FDA to analyze pharmaceutical submissions, giving the agency rapid and easy access to complex data
• Utilization of SEND datasets result in faster FDA review and therefore faster time to approval
• Along with analytical and visualization tools for SEND, it will be possible to query data rapidly across species, compounds and clinical and preclinical disciplines in ways that are not currently feasible, both on the part of the FDA and sponsors

• Form interdisciplinary SEND team (preclinical science, regulatory affairs, compliance, quality assurance, information technology, finance)
• Decide to develop SEND data conversion expertise in-house or to outsource
• Prepare your organization for the changes in workflow, timelines, resources, budget, training and personnel needed to comply with the SEND requirements, regardless of whether SEND dataset preparation is done in-house or outsourced
• Map the terminology utilized in your studies to the controlled terminology glossary required by the FDA
• Produce a number of SEND datasets prior to an actual FDA submission
• If you are a sponsor, learn how to work with your CROs to receive the study data they produce in a format that is conducive to creating SEND datasets
• If you are a CRO, be prepared to deliver partial or whole datasets to your sponsors

As a leading global provider of software and solutions for preclinical research and development companies, PDS stays informed with SEND standards, best practices and FDA expectations by being highly involved in the SEND community. PDS is a member of both PhUSE and CDISC.

The PDS team has developed the industry’s most comprehensive line of intuitive software and services to help get your team SEND-ready. PDS offers 2 options:

What Is SEND Express?

PDS’ SEND Express™ business unit offers a highly cost-effective service for companies looking to outsource the creation of their SEND datasets. SEND Express streamlines and simplifies your SEND dataset creation process by providing a turnkey service supported by a team of preclinical experts and data managers dedicated to SEND.

• Our US-based SEND Express™ business unit operates as an extension of your team 
• Maximizes efficiency while maintaining high quality and speed without impact on your internal resources
• Aggregates and harmonizes your data from multiple information systems and file formats to produce a SEND dataset that is ready for submission
• All work is done in the US within a GLP-compliant data center
• Your IND or NDA SEND submission is guaranteed to be FDA compliant 

What Is TranSEND?

TranSEND is a flexible, all-encompassing and easy-to-use software solution that facilitates the process of translating preclinical data from its source to SEND format.

• Effectively aggregates and translates data from multiple organizations and LIMS
• Produces one harmonized SEND dataset, including define.xml and define.pdf, the Study Data Reviewer’s Guide (SDRG) and the validation report as required by the FDA
• Available as either a hosted system (SaaS) or installed in your IT environment 

The SEND Submission Process With PDS