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.

• Eliminate manual QC processes
• Reduce reporting time up to 75%
• Enforce analysis and reporting best practices

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.

Select study details, report format and output preferences. Report graphs and tables are produced in strict adherence to detailed formatting requirements.

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)

• Short-term Toxicity and TK studies (rodents, higher mammals)
• Carcinogenicity studies (transgenic mice)
• CV, CNS studies

Post IND (Non-Clinical Studies)

• Longer-term TK studies (higher mammals)
• Reproductive Toxicology (genotox, placental)
• Carcinogenicity studies 
• Biomarker / PD response studies

Post IND (Clinical Studies)

• PK studies – Single ascending dose, Multiple ascending dose, Bioequivalence
• Biomarker / PD response studies
• Exposure / response studies