Savante

SEND Intelligence Services

Streamline study submissions

The Most Automated and Integrated SEND Solution Available

The right tools can make any task easier. That is why Xybion offers a SEND intelligence service to assist you in submitting final study results to the FDA.

The Standard for Exchange of Nonclinical Data (SEND) is the required format for the submission of toxicology study data to the FDA. By standardizing the format in which data is submitted, SEND impacts data collection and aggregation by harmonizing study designs and normalizing the terminologies used by scientists.

Our SEND service delivers the complete SEND dataset, define.xml, and study data reviewer guide. We provide this using our own Savante application, incorporating trial design, animal demographic data, importing data from a variety of sources, producing these deliverables for regulatory submission and quality checking against the final study report.

SEND Study Services

SEND dataset verification

SEND organizational consulting

SEND Outsourcing

The Xybion SEND intelligence service produces SEND IG v3.1 data sets without any need for the acquisition of a new system or increased staffing.

Data Preparation Services with Artificial Intelligence

Xybion provides a rich toolset, SEND subject matter experts, and machine learning technology for packaging nonclinical study data into the standardized electronic dataset to fulfill regulatory submission requirements.

Upon creation of the SEND product, files may be automatically ingested into our document management system and placed immediately under version control.

“The Xybion team keeps abreast of changes and interpretations of SEND standards by actively participating in industry standards groups and FDA meetings. Our user community, including top pharma and CRO organizations across the world, actively use our service to automate SEND dataset production.”
Dr. Pradip K. Banerjee
Dr. Pradip K. Banerjee
Chairman & CEO, Xybion

Who Needs SEND Services?

Data preparation services are perfect for labs that do not conduct the volume of studies necessary to justify the cost associated with the acquisition of new systems or increased staffing. Our experts guide staff through the process, including how to format raw data, study design implications, and terminology to use when collecting data.

Our SEND intelligence 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 provides:

  • SEND guidance for the collection of the preclinical study data (in Pristima XD or another data management system)
  • Secure transmission data between Xybion and its clients
  • Automated transformation of raw data files, along with the creation of the trial design
  • Automated production of SEND IG v3.0 for ongoing studies and v3.1-compliant datasets, including data domains, Define.xml, and study data reviewer guide.

Ready to learn more? Book a free demo.