As a pioneer with the Standard for Exchange Nonclinical Data (SEND) system in Asia, QPS Taiwan CTPS has taken a leadership role in implementing and using the SEND data format.
The FDA Guidance Document from March 2019, Study Data Technical Conformance Guide, states on page 16 that, “The Standard for Exchange of Nonclinical Data (SEND) provides the organization, structure, and format of standard nonclinical (animal toxicology studies) tabulation datasets for regulatory submission. The SEND Implementation Guide (SENDIGv3.0) supports single-dose general toxicology, repeat-dose general toxicology, and carcinogenicity studies. SENDIG v3.1 additionally supports respiratory and cardiovascular safety pharmacology studies.”
At QPS Taiwan we view the opportunity to change, develop, and adopt new methods and systems as investments in ourselves that make us better partners and increase the value of the service that we provide to our sponsors, from small biotechs to large pharmaceutical companies.
With open minds and steady steps, QPS Taiwan CTPS bravely faces the trends in the marketplace and sets up the milestone for others. To date, we have completed more than 10 studies in SEND packages and successfully submitted all 10 to the FDA.
Since 1995, QPS has provided discovery, preclinical, and clinical drug development services. An award-winning leader focused on bioanalytics and clinical trials, QPS is known for proven quality standards, technical expertise, a flexible approach to research, client satisfaction and turnkey laboratories and facilities. For more information, visit www.qps.com or email [email protected].