Instem and the PharmQuest have announced plans to launch Submit, a fully integrated non-clinical solution that will help pharmaceutical companies comply with the FDA’s adoption of a standardized format for collecting, organizing and exchanging non-clinical research data.
Submit is a fully-scalable set of software modules that facilitates the conversion of data from any source system into Standard for Exchange of Non-Clinical Data (SEND) format. SEND focuses on toxicology studies, and utilizes the same principles and rules that were developed for clinical data interchange by the Clinical Data Interchange Standards Consortium (CDISC).
Submit tools further enable the FDA, sponsors and their partners to visualize and analyze SEND formatted data on-demand through a web-based system. This module, known as ToxVision, was developed in collaboration with the FDA for their reviewers to analyze and process study data submitted by the pharmaceutical industry.
Instem and PharmQuest will official release Submit at this year’s Society of Toxicology (SOT) show in California in March. Instem and PharmQuest will also be announcing their first customer at the show.
Submit will be available as an on-site system and, for smaller organizations that cannot afford to purchase the system, a service whereby those organizations can send their data on disc and have it returned in SEND format will be provided.