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.
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.
Head of Sales: APAC | Head of Operations: India
Priya is responsible for Xybion business growth in APAC region. She brings over two decades of experience in Business Consulting and Operations Management. Her deep expertise in diversified areas, including strategic alliance and partnership management, diversity and inclusivity initiatives and employee development, will amplify Xybion’s global strategic relationships and will strengthen the company’s executive leadership in India. In her last role at Conduent, she served as Director-Marketing & Bid Management. Prior to this, Priya has worked with Infosys and Covansys (now CSC). Priya holds degrees in microbiology & health management.