SEND Intelligence Services

SEND Intelligence Services enable companies to automate the transformation of raw data files of preclinical research and the production of SEND IG v3.1 data sets without any need for the acquisition of a new system or increased staffing. Xybion’s Savante® is one of the first on the market to achieve full compliance with SEND IG v3.1 with a validated solution.

SEND is a standard for the collection and formatting of nonclinical data so that it may be included in preclinical data submission to the FDA and other regulatory bodies that adopt the standard. By standardizing the format in which the data is submitted, SEND naturally impacts data collection and aggregation by harmonizing 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 CRO’s may transmit data to their Pharmaceutical clients for purposes other than submissions, such as data analyses and data mining.

Collect, Aggregate and Analyze Nonclinical Data for SEND IG v3.1

All organizations now conducting or contracting preclinical studies with the intention to submit to the FDA must require the final results of each study to adhere to SEND standards. Xybion’s user community includes top Pharma and CRO organizations across the world who have participated in the design and have become accustomed to the most automated SEND data set production process provided by Savante. Xybion’s Savante is one of the first on the market to achieve full compliance with SEND IG v3.1.

Xybion has developed a rich tool set and has a wealth of SEND data set development experience through the development of its Savante module. Unlike some companies with individual tools addressing a specific aspect of the SEND preparation process, Xybion’s Savante 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 data set – Define-XML and Study Data Reviewer’s 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 data sets, nor maintain 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 a new system or increased staffing; this is where Xybion’s SEND services come in.

Utilizing the same Savante system already in use at our client sites, Xybion can securely receive the client raw data, ingest the data into Savante and automatically produce the Define-XML data set and Study Data Reviewer’s Guide – then securely return the complete package to the client. Our information systems, toxicology, and regulatory experts can guide the client’s staff in terms of formatting the raw data, study design implications and the terminology to use when collecting data.

Savante 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 data set so each client is assured of the quality of the SEND data set.

Salient Features of SEND Intelligence Services

  • SEND guidance for the collection of the preclinical study data
  • Secure data transmission between Xybion and its clients
  • Automated transformation of client’s raw data files and import into Savante along with creation of the trial design
  • Automated production of the SEND v3.1 data set including the data domains, Define-XML and Study Data Reviewer’s Guide
  • Internal review of SEND data sets and quality assurance of SEND compliance

Can SEND Intelligent Services Support any Preclinical System?

Xybion provides the industry-best intelligent services to all clients, irrespective of data management tool they use and the SEND dataset services to their CROs, who do not provide SEND-compliant submission data sets.

Additionally, they can help produce both SEND IG v3.0 for ongoing studies and v3.1-compliant datasets for studies that run in any preclinical systems.