WILMINGTON, Mass.—Charles River Laboratories International Inc. recently announced that it had invested in Resero Analytics, a software company focused on providing solutions to the biopharmaceutical industry to harness its data. As part of its investment, Charles River will collaborate with Resero Analytics and is now the exclusive contract research organization (CRO) partner for TurboToxicology, a report-generation tool that enables faster delivery of high-quality reports.
“With a global network and the most robust portfolio in preclinical research, Charles River was the clear CRO partner of choice for TurboToxicology,” said Dr. Dave Watson, founder and CEO of Resero Analytics.
TurboToxicology is designed to enable the efficient production of consistent formatted reports, helping to accelerate this step in the drug development process and thereby accelerating Investigational New Drug or New Drug Approval submissions.
As part of this, TurboToxicology analyzes nonclinical data in SEND (standard for exchange of nonclinical data) and other structured data formats. SEND is an implementation of the Clinical Data Interchange Standards Consortium (CDISC) Study Data Tabulation Model that provides a framework for the standardized, electronic representation of individual research model study data. SEND is intended to increase the effectiveness and efficiency of data review for regulatory submissions.
The tool also conducts statistical analyses, applies proprietary algorithms and displays study results via visually appealing user interfaces. The tool then formats the data in concert with the scientist’s interpretation, to generate a complete written report that is inclusive of text, tables, figures and legends.
According to the companies, leveraging structured data, including SEND, allows TurboToxicology to expedite interpretation and ensure consistency across authors and sites producing toxicology reports, while enabling sponsor companies to make quicker decisions by providing robust data early in the reporting process. They note further that “This time savings is essential as sponsor companies work to move potential therapeutics through the drug development pipeline efficiently, without sacrificing quality.”
“By implementing solutions that increase efficiency in reporting, our goal is to give our clients the gift of time. By alleviating some of the upfront administrative work, TurboToxicology’s report generation tool will allow time for greater focus on other areas of drug development,” concluded Birgit Girshick, a corporate executive vice president at Charles River in charge of discovery and safety assessment, biologics testing solutions and avian vaccine services.