clinical study reporting
Clinical pharmacology and pre-clinical toxicology groups are under tremendous pressure to provide accurate and timely reports in support of critical product milestones. In some situations, this can involve the use of disparate systems and manual processes, increasing the risk of error and requiring redundant validation steps. Clinical Study Reporting eliminates manual processes, providing a point-and-click workflow for standardized reporting on pharmacokinetics, toxicokinetics and pharmacodynamics for a wide collection of studies.
Clinical Study Reporting supports a consistent and automated process from data acquisition through document generation and distribution. There is no cutting-and-pasting or programming required for producing standard reports; and all reports adhere to regulatory requirements including 21 CFR 11 and GxP.
Pre-clinical, Non-clinical, Clinical Studies; Analyses & Reports
Insightful Clinical Study Reporting supports all pre-clinical, non-clinical and clinical study types, as well as required regulatory components.
IND Filing (Pre-Clinical Studies)
Post IND (Non-Clinical Studies)
Post IND (Clinical Studies)