To reduce the burden of SEND compliance! We provide comprehensive services related to SEND, including SEND data creation, document preparation, and support for FDA applications!
As of December 17, 2016, the FDA requires the submission of SEND data compliant with CDISC for non-clinical trials starting after this date. Inari Research provides total support from the creation of SEND data packages to FDA submissions. We utilize solutions from Instem, a company known for its high quality and reliability, and which is GLP certified. The biggest risk in SEND submissions is the loss of time and costs due to FDA rejections (refusals to accept). Additionally, there may be burdens related to overall compliance, uncertainty about what to prepare, and the latest trends regarding SEND. If you have any concerns, please feel free to consult with us. 【Service Features】 ■ Comprehensive total support ■ Organizational and comprehensive responses to meet customer needs ■ Creation of reliable datasets by dedicated teams and study directors ■ Support for trials at other facilities is also available ■ Data integration from multiple sites is possible ■ The latest trends and case information on regulatory requirements will be delivered promptly in seminars, etc. *For more details, please refer to the PDF materials or feel free to contact us.
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basic information
【Service Contents】 ■ Creation of SEND Data Package ・SEND Dataset (.xpt) ・Define File (Define.XML, Define.pdf) ・Study Data Reviewer's Guide (nSDRG) ・Validation Report (Pinnacle 21) ■ SEND Report ■ SEND Statement ■ Mapping * For more details, please refer to the PDF materials or feel free to contact us.
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For more details, please refer to the PDF document or feel free to contact us.
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Company information
Our company is located in the nature-rich city of Ina, Nagano Prefecture, surrounded by two Alps, and has been serving our customers as a non-clinical trial contract research organization (CRO) for 50 years. Since 2022, we have become a member of the Shin Nippon Science Group, expanding and enhancing our contract testing items and analyses, and we can quickly respond to the procurement of various testing materials (such as animals). Non-Clinical Trial Business We accept safety and efficacy testing for pharmaceuticals, chemicals, pesticides, food, medical devices, and more. We conduct in vivo tests using small animals, rabbits, dogs, and monkeys, as well as in vitro tests using bacteria and cells, and various alternative method tests. Additionally, we specialize in the creation of SEND data required for FDA applications for new drugs, and we also undertake work related to SEND conversion and QC for data creation and conversion only. Our facility was the first in Japan to obtain full accreditation from AAALAC International (the Association for Assessment and Accreditation of Laboratory Animal Care International), and we are committed to international standards of animal welfare. We also propose tests necessary for various applications and registrations in compliance with regulations in different countries and regions.
