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 provides a single package that allows users to define trial designs, import data from a variety of sources, and produce the complete SEND dataset, define.xml, and study data reviewer guide all at once.
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.
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.
Head of Quality Assurance
Heidi leads Xybion’s Quality Assurance practice. She has over 20 years’ experience in designing and implementing quality assurance policies. Since joining Xybion in 2000, Heidi worked with several clients to design quality policies and ensure compliance. She is responsible to hosting Xybion customer audits. Heidi has a BA degree in Biology from The King’s College.