Making PK/PD as easy as ABC.
You have a fabulous pharmacometrics team. They’re smart, talented, experienced, and know PK/PD inside and out. But that doesn’t mean they don’t need a little help every once in awhile. What we can do is work with your team, and lend a hand with specific aspects of the development process. Basically, we’ll do the dirty work so you don’t have to.
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 Simulations Plus, 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 over 20 years, and we are now offering this experience to you. As pharmacometric modeling and simulations become 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. Simulations Plus 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 us will ensure your plan is complete, accurate, and coherent.
Dataset errors are often subtle and difficult to detect. Forensic assessment of your dataset by Simulations Plus 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. Our experts can perform nonprogrammatic data checks, such as requirements management, code review, program verification, and comparison to raw data. Our scientists 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. Simulations Plus has developed canonical report templates to promote inclusion of content recommended in regulatory guidances. Forensic assessment of your submission by us 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 Simulations Plus 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.
Graph Library and Standards
Speed the build and ensure the quality of analysis-ready data sets…..
Simulations Plus has developed an extensive graph library with set standards that allow us to quickly generate pictures of data pooled from multiple studies. The graph library generates:
- Diagnostics that can be used as part of quality control efforts,
- Informative guides to direct model building efforts, and
- Graphical displays of hard-won insights to tell the story of your analyses to R&D teams.
Modeling naturally involves the pooling of data from multiple studies, often up to 20 or more studies. Just running a model up against 20 studies, without having the graphical insight into your data is nothing more than a guessing game, and a black box to the extended R&D team. Yet, graphing of 20 studies with a time-crunched deadline, seems impossible.
At Simulations Plus we have developed a suite of processes, requirement standards, templates, macros, and technologies that allow our modelers to be able to spend the time thinking about your data by looking at the exploratory graphical analyses with your extended team. Through this process, we understand what the impact on the model will be and what it means to your development program. With this knowledge and insight, our modelers then are able to systematically approach model building to achieve the best predictions possible for your critical decision-making milestones.