Protect yourself and your company’s assets against dataset errors, incomplete analysis plans, and disorganized reports before you submit your package to a regulatory agency. At Cognigen, we’re experts in all things related to model-based research and drug development. We have used proactive quality assurance techniques on our own modeling and simulation projects for almost 20 years, and we are now offering this experience to you. As pharmacometric modeling and simulation becomes integral to critical path decision making, our forensic review and feedback will help you avoid costly surprises.
Data analysis plans for pharmacometric analyses can be missing major content, including descriptions of planned exploratory data analyses, biomarker sampling strategies, study designs for the studies contributing data to the modeling effort, planned covariate analyses, and methods used to generate individual exposure methods. Cognigen has developed canonical documents that contain standard document sections and content suggestions to facilitate adherence to content standards. Forensic assessment of your data analysis plan by Cognigen will ensure your plan is complete, accurate, and coherent.
Dataset errors are often subtle and difficult to detect. Forensic assessment of your dataset by Cognigen will ensure the dataset was built correctly; that is, valid and appropriate assumptions were applied, and no critical errors were made in the processing and pooling of study data. In addition, a forensic assessment can determine the adequacy of the data for the analyses. Cognigen can perform nonprogrammatic data checks, such as requirements management, code review, program verification, and comparison to raw data. Cognigen can also perform programmatic data quality checks to detect potential outliers, to verify record counts and listings against expectations to confirm accuracy, and to generate and review graphical displays that will assist in determining if errors were made in the manipulation of the data.
Pharmacometric Technical Reports
Well written and concise technical reports can make your submission stand out with the regulators. Cognigen has developed canonical report templates to promote inclusion of content recommended in regulatory guidances. Forensic assessment of your submission by Cognigen can ensure that your technical reports include these common omissions: influence of study dropouts, description of planned exploratory data analyses, rationale for selecting covariates and for deciding which covariates were evaluated on which parameters, and methods for calculating derived variables.
Why choose Cognigen to review your submission package?
- Our experience is unique and extensive.
- Our preparation is comprehensive.
- Our process is efficient.
- Our communications are secure and to the point.
- Our quality is assured.
- Our reputation is hard-earned.
- Our forensic review will arm you with knowledge, credibility, and confidence.
We would be happy to speak with you in more detail about our Forensic Pharmacometric Services—call us at +1.716.633.3463 or send us a note
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