Xybion Corporation

SEND Services

Streamlining study submissions

The most automated and integrated SEND solution on the market

Overview

SEND 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.

Our SEND Services module adjusts to varying data sources and terminologies that are already being utilized to transform data to be SEND compliant, and our professionals utilize a validated environment in the production of the SEND data set so you are assured of quality.

Xybion’s Savante® is one of the first on the market to achieve full compliance with SEND IG v3.1 with a validated solution.

Securely receive your raw data
Ingest data into our system
Automatically produce Define.xml dataset and study data reviewer guide
Securely returns the complete package

SEND service provides a single package that allows users 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.

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’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.

How Savante works

Key Features

  • SEND guidance for the collection of the preclinical study data
  • Secure transmission data between Xybion and its clients
  • Automated transformation of raw data files, along with creation of trial design
  • Automated production of SEND 3.1 dataset, including the data domains, Define.xml and study data reviewer guide

Data Preparation Services with Artificial Intelligence

We provide a rich toolset and built in artificial intelligence for packaging nonclinical study data into a standardized electronic dataset to fulfill regulatory submission requirements. Our user community, including top pharma and CRO organizations across the world, actively use our service to automate SEND dataset production.

 Our New

SEND 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 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.

Xybion’s SEND Services module is one of the first on the market to achieve full compliance with SEND IG 3.1

© Xybion Corporation 2020