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SEND Dataset Preparation Services

The most automated and integrated SEND solution on the market.

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SEND Intelligence Services Overview

SEND is a standard for the collection and formatting of nonclinical data so that it may be included in the submission to the Food and Drug Administration and other regulatory bodies that adopt the standard. SEND was developed by the Clinical Data Interchange Standards Consortium (CDISC), a non-profit organization whose goal is to improve the impact of clinical research through developing standardized data formats and terminology for clinical data (SDTM and ADaM) and non-clinical data (SEND) collection, analysis, and transmission. By standardizing the format in which the data is submitted, SEND naturally impacts the data collection and aggregation by harmonizing the study designs and normalizing the terminologies used by scientists today. This homogenization of the preclinical data facilitates and leads to efficiencies on the part of the reviewers, accelerating the regulatory review process for NDA, ANDA, IND, and certain BLA submissions.

Importantly, with the standardization of data formats and the normalization of the terminologies used in the dataset, the SEND standard also provides a long-sought transport mechanism by which CROs may transmit data to their pharmaceutical clients for purposes other than submissions—for data analysis and data mining. According to the Food and Drug Administration, the submission of SEND nonclinical datasets is expected to continue to increase in the future. The increasing demand for SEND submissions proves the importance for reviewers to receive standardized data, which will help them save time and increase efficiency in the review process.

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Current Challenges with SEND Submission

The life science industry has struggled with how to achieve SEND compliance while minimizing the impact on day-to-day operations since the Food and Drug Administration mandated SEND submission. Here are a few areas of SEND compliance implementation that CROs and sponsors typically struggle with:

Financial burden

Becoming SEND compliant can be expensive due to the need to hire SEND subject matter experts and expand systems with additional tools to deliver more capabilities.

Labor Intensiveness

The need for increased staffing along with training qualified staff in SEND guidelines to avoid compromised data.

Evolving SEND Standard

The ever-changing expectations of the FDA on nonclinical dataset submissions require organizations to constantly evolve their procedures to ensure full regulatory compliance and adherence.

Increased Number of Studies

The number of studies that an organization holds makes it harder to keep up with timely SEND submissions. Also, merging data from multiple sources can be complicated and time-consuming for organizations.

Lack of understanding of SEND requirements

Many organizations struggle to fully understand the steps required, and in some cases, the investment in the systems to confidently manage SEND.

Solution

Before CDISC SEND, Xybion produced software for FDA submissions in the legacy CDER format before 2000. We have been working continuously with industry stakeholders to shape and develop the SEND standard since 2009. Xybion offers SEND Intelligence services to meet your business needs regardless of the number of studies or datasets being carried out, without spending on new systems or staffing. Our SEND experts continuously review changes to the implementation mandates to assist our clients with the challenges of the ever-changing CDISC-SEND standards.

All organizations now conducting or contracting preclinical studies to submit to the FDA must require the results of each study to adhere to SEND standards. Xybion’s user community, including top pharma and CRO organizations across the world, has participated in the design and has become accustomed to the most automated SEND dataset production process provided by Savante. Xybion’s Savante SEND module is one of the first on the market to achieve full compliance with SENDIG v3.1.1

Xybion has developed a rich toolset and a wealth of SEND experience with the development of its Savante SEND module. Unlike some companies with individual tools addressing a specific aspect of the SEND preparation process, Xybion’s Savante SEND module provides a single package that allows the user to define the trial design, import data from a variety of sources, and produce the complete SEND dataset, Define.xml, and Study Data Reviewer Guide all at once. Upon creation of the SEND products, these files may be automatically ingested into the Savante document management system and placed immediately under version control.

Data Preparation Services

Many organizations do not employ data management systems capable of producing the SEND dataset or maintaining SEND expertise within their scientific data staff. In many cases, the volume of studies conducted by a lab may not justify the cost associated with the acquisition of new systems or increased staffing; this is where Xybion’s SEND services come in.

Utilizing the same Savante SEND module already in production at our client’s sites, Xybion can securely receive the client’s raw data, ingest the data into Savante and automatically produce the Define.xml, dataset, and study data reviewer guide, then securely return the complete package to the client. Our experts guide the client staff in terms of the format of the raw data, the study design implications, and the terminology to use when collecting data. However, the Savante SEND module also empowers our SEND experts to adjust to the varying data sources and terminologies that may have already been utilized and to transform the data to be SEND compliant. Xybion’s

staff utilizes a validated environment in the production of the SEND dataset, so each client is assured of the quality of the SEND dataset.

SEND Intelligence Services Summary

  • SEND guidance for the collection of preclinical study dat
  • Secure transmission of data between Xybion and its clients
  • Automated transformation of clients' raw data files and import into Savante along with the creation of the trial design
  • Automated production of the SEND 3.1 dataset includes the data domains, Define.xml, and Study Data Reviewer Guide

Save Additional Costs with Our Preclinical Solution

Xybion has created a total preclinical solution platform, Pristima XD, to help you improve productivity and reduce costs. If your organization operates using our Pristima XD products, you can save up to 70% of total SEND Intelligence Services costs. Start your free trial today

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