Toxicology
Preclinical safety is a crucial aspect of drug discovery. The goal at this stage is to conduct and assess toxicology, safety pharmacology, genetic toxicology, and reproductive toxicology11. Histopathology, clinical chemistry, cardiovascular, and genetic toxicity assessments generate tens of thousands of individual data points per compound. Success depends on repeatable workflows, strong audit trails, and rapid reporting, and thus study designs, data capture, and reporting need to be streamlined. Advanced in silico toxicology insights provided by Leadscope Model Applier™ may be utilized here for this purpose, in addition to study management solutions Provantis®, Cyto Study Manager™, and NOTOCORD-hem™, which can reduce manual burden and support stronger compliance when researchers are conducting safety studies.
Provantis®: The Leading Preclinical Management Solution
For preclinical study management, Provantis is the industry leader. The GLP-compliant software allows researchers to create protocols, import external data, create final reports, generate data tables, and perform advanced statistical analyses.
In addition to general toxicology functions that support studies across any species and duration, there are specialized modules for pathologists, reproductive toxicologists, teratologists, and pharmacists. As an all-in-one solution, Provantis minimizes data loss, reduces repetitive data entry, supports real-time data sharing across departments, and accelerates turnaround times. Subsequently, organizations such as SRI Biosciences have reported cost reductions up to 18% and halved reporting times upon implementing Provantis.
Optimize Genetic Toxicology Assays Using Cyto Study Manager™
Robust and streamlined toxicology workflows reduce costs, eliminate errors, and confidently satisfy regulatory requirements. Cyto Study Manager is a centralized, GLP- and 21 CFR Part 11-compliant platform designed for the objective analysis and reporting of genotoxicity assays relevant to the toxicology stage of drug discovery.
Cyto Study Manager supports in vitro Ames, comet, micronucleus, chromosome aberration, and neutral red uptake assays, in addition to in vivo comet, micronucleus, and chromosome aberration assays, and has the ability to track DNA packaging events in transgenic rodents. Preconfigured templates and automated data capture save time, while built-in audit trails and electronic signatures improve compliance, overall optimizing genetic toxicology workflows.
NOTOCORD-hem™ For Physiological Data Insights
NOTOCORD-hem features over 160 modules designed to support a broad range of research aims. Specialized modules for cardiovascular, nervous, and respiratory systems, as well as ex vivo and in vivo research, enable NOTOCORD-hem to acquire, visualize, and analyze physiological signals across diverse research areas. These abilities allow NOTOCORD-hem to streamline various experimental setups in one centralized platform, providing a cost-effective alternative to traditional software packages for accessing physiological insight.
With solutions that reduce manual burden, enhance data integrity, and support regulatory requirements, Instem helps organizations strengthen safety profiles and avoid costly downstream delays. As the molecule continues its journey, teams must prepare for the critical CMC phase, where manufacturing, quality, and traceability take center stage. Our next post explores how Instem enables organizations to achieve CMC readiness with confidence.
- Blomme EAG, Will Y. Toxicology Strategies for Drug Discovery: Present and Future. Chem Res Toxicol. 2016;29(4):473-504. doi:10.1021/acs.chemrestox.5b00407 ↩︎
