"SEND Total Support" Inari Research
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.
- 企業：イナリサーチ
- 価格：Other
