The cost of developing a new drug can be as high as $2.9 billion. Even after such a major investment of time and money, only a small percentage of drugs receive FDA approval.
Making it through the Food and Drug Administration application process is difficult. The first step is ensuring that your study data complies with SEND rules. Compliance with SENDIG v3.1.1 can be challenging, though.
Learn more about SENDIG v3.1.1 and how to overcome the complexities of compliance.
SENDIG v3.1.1 is the latest version of the Standard for Exchange of Nonclinical Data Implementation Guide. It provides specific instructions for complying with the Standard for Exchange of Nonclinical Data (SEND).
SEND is the nonclinical implementation of the Study Data Tabulation Model (SDTM). The Clinical Data Interchange Standards Consortium (CDISC) developed and maintains SEND. CDISC intended for SEND to improve the FDA submission process.
SEND provides guidance for nonclinical tabulation datasets. The datasets are used for submission to regulatory authorities or for exchange between organizations. Under SENDIG v3.1.1, you must package nonclinical data points into a standardized electronic dataset.
SEND covers all aspects of nonclinical tabulation datasets, including:
• Organization
• Structure
• Format
CDISC released SENDIG v3.1.1 in 2021. Support for this version began in February 2022.
Compliance with SENDIG v3.1.1 has many benefits. Data standards help the FDA handle submissions more effectively. It streamlines many parts of the submission process, including:
• Reception
• Processing
• Review
• Archiving
It makes more consistent analysis possible. The FDA can flag areas of concern more accurately.
SEND streamlines communication between CROs, sponsors, and the FDA. It facilitates cooperation while studies are ongoing as well as during data submission.
Compliance with SENDIG v3.1.1 can improve research and development for pharmaceutical companies. SEND datasets can provide insights that reduce failure rates and improve safety. Compliance can accelerate the time to market. It helps the drug approval process move more quickly.
SEND data can increase the return on existing investments. It allows for better data visualization and statistical analysis.
Compliance with the latest SEND rules is required. The date that compliance with SENDIG v3.1.1 becomes mandatory depends on the type of study, though. The applicable date is March 15, 2023, for electronic submissions of:
• New drug applications
• Abbreviated new drug applications (NDAs)
• Some biologics license applications (ANDAs)
• Some investigational new drug applications (INDs)
The SENDIG format requirement applies to the date the study started. FDA can refuse to file applications whose study data don’t conform to SEND.
Compliance with SENDIG v3.1.1 is mandatory. However, compliance can be challenging. It requires a significant investment in infrastructure and a commitment to training and development.
A lack of IT infrastructure can be a significant barrier to SEND compliance. A database and visualization tools with sufficient capacity to handle the demands of SEND are major investments. A storage solution for warehousing large files is also necessary.
Personnel with the experience and qualifications to analyze the complexities of SEND data are another large investment.
SEND has already been through several versions. New versions are in development. This almost continuous evolution affects many aspects of compliance, including:
• Software
• Staffing
• Training
• Data handling
• Data interpretation
The cycle of change can cause confusion and inconsistency among sponsors, labs, CROs, and other stakeholders.
Many nonclinical studies have phases at multiple test sites. All of this data must be integrated into a single SEND package. However, the data can vary in quality and completeness.
Different labs may use different systems for collecting data. Legacy data collection and reporting processes can lead to gaps. These inconsistencies can create delays in the study submission process.
Maintaining effective communication between the CRO, sponsor, and any third-party labs is critical for SEND compliance. All the organizations need to work together seamlessly to ensure that study data meets SEND rules.
Poor communication can delay the project. Uncertain knowledge of a contracted laboratory’s processes can make integrating the data more difficult.
The right SEND intelligence service can help you overcome the challenges of SENDIG v3.1.1 compliance. You benefit from a complete and high-quality SEND package without the expense of new infrastructure or staffing. SEND intelligence solutions can include a variety of services, such as:
• SEND study services
• Verification of SEND datasets
• Organizational consulting
• Complete SEND outsourcing
A data management system helps you collect the right preclinical study data. It aids in ensuring that data is correctly formatted from the start of the study. Using a SEND managed services provider facilitates secure communication among stakeholders.
Xybion is a leading provider of unified cloud platforms for research and development. Xybion’s SEND intelligence solutions offer a range of services, including the delivery of:
• Complete SEND dataset
• Define.xml guide
• Guide for Study Data Reviewers
Xybion SEND Intelligence Service can convert legacy study data into SEND files or create SEND datasets as your study unfolds.
The Xybion Savante application imports data from a variety of sources and quality checks them for the final report. Savante is one of the first validated solutions to achieve full compliance with SENDIG v3.1.
Xybion’s SEND intelligence solutions convert and verify datasets faster and more accurately than those of other vendors. Proprietary technology uses artificial intelligence and machine learning. SEND subject matter experts collaborate with technology to provide a seamless automated workflow.
Xybion stays up-to-date on changes in SEND rules. The team participates in industry standards groups and FDA meetings. You know that Xybion software solutions will help you comply with the right version of SENDIG.
Complying with SENDIG v3.1.1 is essential for your FDA submissions. Following SEND rules can benefit your data collection and analysis. Failure to comply can lead to the rejection of your application.
SEND intelligence services from Xybion can simplify your SEND compliance. We have the most automated and integrated SEND solution available. We can transform your data into a verified, SEND-compliant package.
We also provide consulting services to help your organization manage SEND compliance more effectively. Talk to our SEND experts today to see how Xybion can help you comply with SENDIG v3.1.1.
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