PK/PD Support

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 a while. 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.


CDISC Data Assembly Services.

You’ve trusted Cognigen to build your NONMEM datasets, now let us build your CDISC SDTM domain and ADaM datasets.  READ MORE....

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Data Assembly and Programming

At Cognigen, not only do we excel in data assembly for population-based analyses, but we’re the only company in the world with a definitive niche in the field. Our experience in data assembly is unique and extensive. In fact, between 2001 and 2007, we wrote 40,950 data programs and we are still programming strong.

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Forensic Pharmacometrics

As part of Cognigen’s Forensic Pharmacometrics services, we will review your submission package and provide the feedback that will arm you with knowledge, credibility, and confidence—knowledge to achieve critical milestones successfully, credibility to withstand regulatory scrutiny, and confidence that you will avoid costly surprises down the road. We will systematically review data elements, verify analysis variables, review code, verify data integrity, check assumptions, and ensure the dataset has been built correctly. We will also review documentation for accuracy, completeness, and coherence of the scientific strategy.

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Graph Library and Standards

Speed the build and ensure the quality of analysis-ready data sets.....

Cognigen has developed an extensive graph library with set standards that allows 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. 

At Cognigen 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 develpment program.  With this knowledge and insight, our modelers then are able to systematically approach model building to acheive the best predictions possible for the your critical decision making milestones.  Join us to actively discuss your project, as Data Loves Discussion!  

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Leading the way to high-quality, timely analysis-ready data set delivery

Cognigen, a SimulationsPlus company has long stressed the need to address the data assembly challenges of model-based drug development. This project takes a new look at the data requirements specification process in light of the emergence and broad acceptance of CDISC standards. We see first hand, the struggle that companies have in data programming and the delivery of high quality data. Our systematic approach to requirements definition has broad applicability and we would be happy to discuss opportunities to deploy a customized data requisition system for your company.

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Pharmacometric Enterprise Support

The Pharma of the Future (PoF) initiative at Cognigen is focused on the identification and application of people, process, and technology enhancements in support of model-based drug discovery and development. The purpose of early PoF initiatives has been to examine and improve the essential functional elements required to successfully generate timely and relevant modeling and simulation results. The goals of these efforts are to reduce costs, increase productivity, and raise the standard of quality and effectiveness of M&S work products. Examples of early work include:

  • Formalization of the M&S process, including provisioning and execution workflows
  • Improving the requirement specification process
  • Implementing a centralized interdisciplinary team communication system
  • Developing strategies for addressing informatic deficiencies
  • Creating tools for documenting and communicating the modeling process
  • Workshops to identify the strategic gaps, operational gaps, and readiness reviews of implementing model-based drug development at pharma companies

The value of the tools and processes that have come out of the PoF program has been successfully demonstrated during the execution of M&S projects for both large and small pharma and biotech companies.

 


Regulatory Submissions and Scientific Writing

Cognigen can prepare the pharmacology sections of documents — including IND, CSR, EOP2a briefing book, SAP, FTR, CTD, and NDA — to support your important regulatory milestones. We’ve developed taxonomies that not only guide the writing of these documents, but make sure you’re addressing all the critical components that will be used throughout the lifecycle of drug development.  Our goal is to minimize or eliminate the questions posed by regulatory reviews, while balancing the cost and time it takes to develop any of these documents. Our analysis plans and reports also help anyone — from a new team or employee to a licensing company to a regulator agency — understand what was done any why, which reduces the need for rework.