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What is SENDIG v3.1.1 from CDISC?

All pharmaceutical companies, biotechs and contract research organizations (CROs) will soon be required to prepare data according to the CDISC formats. Sponsors will be required to use these formats by the FDA, and consequently, CROs are increasingly expected to provide study results in these formats. Working with commercial software vendors can help ease the burden of complying with evolving format standards, while also helping you leverage best practices in a GLP regulated environment. 
All pharmaceutical companies, biotechs and contract research organizations (CROs) involved in preparing nonclinical data for submission to the FDA will soon be required to prepare data according to the CDISC SENDIG v3.1.1 (Standard for Exchange of Nonclinical Data) format. Whether you are a sponsor company or a CRO, you will be required to conform to a consistent format and terminology, which will streamline inter-organizational data exchange and generally enable the FDA to compare and analyze study information, potentially accelerating the approval process and throughput, In addition to the new data format, you need to ensure that your processes continue to meet Good Laboratory Practice (GLP) and CFR-21 Part 11 regulations and that you have the documentation to prove it.  Companies will benefit from addressing the new requirements before the deadline comes into effect in December of 2016.  However, achieving compliance is not a trivial matter and may involve a significant investment in IT infrastructure and/or modifications to current business processes.
CDISC Standards Clinical Research Process

What is the Standard for Exchange of Nonclinical Data Implementation?

The Standard for Exchange of Nonclinical Data Implementation Guide (SENDIG v3.1.1) was developed by the Clinical Data Interchange Standards Consortium (CDISC).  It is intended to guide the organization, structure, and format of standard nonclinical tabulation datasets. Pharmaceutical companies and contract research organizations will soon be required to comply with SENDIG v3.1.1, which establishes certain data use and implementation standards for non-clinical datasets that are included in new drug applications and other regulatory approval documents. SENDIG v3.1.1 sets the standard for pre-clinical dataset files, containing electronic records of protocol design, animal demographics, animal exposure and animal observation data, detailing their content and terminology.

Companies and organizations submitting study data to the FDA should begin addressing the dataset requirements now, before the deadlines approach next year.

Companies and organizations submitting study data to the FDA should begin addressing the dataset requirements now, before the deadlines approach next year. These standards do not change the requirements for the design, conduct and analysis of the studies; however, gaining an understanding of the standards for data record submission and the standardization of control terminologies may well require changes in your data collection and reporting systems. Many companies are already incorporating standard terminologies into their data collection systems or are working hard to make plans to do so.
The SENDIG v3.1.1 applies to studies in single-dose general toxicology, repeat-dose general toxicology, and carcinogenicity studies. Work is already underway to add formats for the electronic data records of safety pharmacology and developmental and reproductive toxicology studies.
By creating a standard for submission data, CDISC SENDIG v3.1.1 is expected to streamline the communication between contract research organizations and sponsors. CROs are increasingly using these formats to send interim data sets to sponsors so that sponsors can be aware of the progress of their studies and do early analysis of the results.  More and more, sponsors are looking to CROs to provide SENDIG v3.1.1 compliant data sets to simplify the submission process. For CROs, implementing the systems and processes to produce SENDIG v3.1.1 compliant data can provide an important differentiator in a highly competitive market.

GLP and electronic data management

The data that makes up these submissions must be collected following the already established GLP and 21 CFR-Part 11 regulations. The data submitted in the SENDIG v3.1.1 format must accurately represent the study setup and observations, and laboratories are required to ensure this is the case. The SENDIG v3.1.1 submission requires precise documentation of dates, times and methods followed. For this reason, it is more important than ever that your processes support these regulations and that you have the validation framework in place to prove that your processes are being followed. 

Data accuracy and workflow verification is essential in complying with increasingly stringent regulatory standards. The FDA emphasizes the importance of electronic signatures, closed systems and security features which guarantee that the management of laboratory data is tightly controlled and not susceptible to error or tampering.  In addition, conforming to a particular data standard (such as SENDIG v3.1.1) requires an on-going due diligence.  This burden can be eased by choosing a commercial software system that keeps in step with changing data format requirements.
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CDISC Standards Model
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How pharmaceutical companies and CROs can become SEND-compliant?

For NDA, ANDA, and certain BLA submissions, studies which start after December 18th, 2016, must have their data electronic submitted following the CDISC SENDIG v3.1.1 standards. For commercial INDs and amendments, except for submissions described in section 561 of the Federal Food, Drug, and Cosmetic Act, this is true for studies which start after December 18th, 2017.  Most companies are interpreting this as a need to be SENDIG v3.1.1 ready before the end of 2015.
Companies looking to ensure that their data management is SENDIG v3.1.1-complaint should leverage software solutions that provide data capture and assembly options out-of-the-box.  This will reduce your risk and generally help you leverage best practices, while also reducing the cost of maintaining such systems on your own.
Savante facilitates the consolidation and formatting of non-clinical data and is designed to produce SENDIG v3.1.1 compliant data submissions to the FDA from a variety of data sources (including but not limited to Xybion’s Pristima XD pre-clinical data collection system). 

Xybion’s CQRM XD is a compliance and quality management solution that works in conjunction with Savante – the company’s state-of-the-art data warehousing and SENDIG v3.1.1 data preparation tool. It is used to organize and manage your SOPs and electronic content including SENDIG v3.1.1 datasets and non-clinical study reports.  It has modules to create a master schedule of studies, approval workflows, and to ensure you are following GLP regulations through documentation, training, and internal audits.

Xybion’s unique solutions offer advanced features that effectively bridge the gap between the business processes, animal management and scientific aspects of research absent in many of today’s pre-clinical solutions.
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