![]() ![]() Our experts can perform non-programmatic data checks, such as requirements management, code review, program verification, and comparisons to raw data. In addition, a forensic assessment can determine the adequacy of the data for the analyses. Forensic assessment of your dataset by Simulations Plus will ensure the dataset was built correctly, confirming that valid and appropriate assumptions were applied, and no critical errors were made in the processing and pooling of study data. Datasetsĭataset errors are often subtle and difficult to detect. Forensic assessment of your data analysis plan by Simulations Plus will give you confidence that your plan is complete, accurate, coherent, and ready for regulatory scrutiny. Simulations Plus has developed canonical documents that contain standard sections and content suggestions to facilitate adherence to content standards. ![]() As pharmacometric modeling and simulations become more and more integral to critical path decision making, our forensic review and feedback will help you avoid costly surprises.ĭata analysis plans for pharmacometric analyses can be missing major content, including descriptions of planned exploratory data analyses, biomarker sampling strategies, designs for the studies contributing data to the modeling effort, planned covariate analyses, and methods used to generate individual exposure measures. We have used proactive quality assurance techniques on our own modeling and simulation projects for over 25 years, and we are now offering this service to you. At Simulations Plus, we’re experts in all things related to model-based research and drug development. ![]() ![]() 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. Basically, we’ll do the dirty work so you don’t have to. We can work with your team and lend a hand wherever you need that extra support: developing a rock-solid modeling and analysis plan, creating accurate analysis-ready datasets, providing an expert review and second set of eyes to quality check your modeling efforts, assisting with regulatory reporting and regulatory interaction support, or just as your overflow option when your team is fully booked. But that doesn’t mean they don’t need a little help every once in a while. They’re smart, talented, experienced, and know PK/PD inside and out. You have a fabulous pharmacometrics team. ![]()
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