ToxQuest™
- The solution for electronic submission and review of toxicology data.

The ToxQuest family of products include ToxSub™, ToxVision™, ToxConnect™ and SEND Validator. These products facilitate the conversion of animal toxicology and carcinogenicity data into SEND format and enable analysis and review of this data.

PharmQuest executed a Cooperative Research & Development Agreement (CRADA) with the US Food and Drug Administration (FDA) in April 2002. This led to the development of a software system for the FDA to receive and analyze Nonclinical data from pharmaceutical companies. As a part of the CRADA, the FDA’s Center for Drug Evaluation & Research (CDER) and PharmQuest created an industry-regulatory agencies consortium. Its mission was to standardize the submission of nonclinical data by Pharmaceutical companies to the FDA, CFSAN (Center for Food Safety and Nutrition) and CVM (Center for Veterinary Medicines). This consortium, formed in June 2002, currently includes representatives from a majority of the top-20 Pharmaceutical companies, multiple Contract Research Organizations (CROs), three regulatory agencies (CDER, CFSAN, CVM) and a number of leading software vendors. The consortium released a version of the toxicology and carcinogenicity data submission format called the Standard for Exchange of Nonclinical Data (SEND).

CDER has undertaken a pilot project as a part of this broader initiative. The purpose of the pilot project is to support the development of software system designed to facilitate the review and evaluation of electronic nonclinical datasets, and to obtain feedback from reviewers and pharmaceutical companies on the creation and use of SEND.