Our many talents.

While our main focus is helping clients with the selection and justification of dosing regimens, we also strive toward advancing the industry through model-based development. Here are the nitty-gritty details of what we offer.


Pharmacometric Analyses and Support

  • Strategic analysis planning support, including Data Analysis Plan development
  • Study design and PK/PD sampling strategy development
  • CRF and protocol development
  • Data management and analysis dataset creation
  • Literature review and meta-analysis
  • Population PK/PD model development
  • Exposure-response analyses
  • Clinical trial simulations
  • Technical report writing

Data Assembly and Programming

  • Comprehensive data management and assembly services
  • Development and review of analysis plans and translation into programming requirements
  • Innovative web-based tools for programming requirements definition management
  • Real-time data assembly, reporting, and error checking
  • Exploratory data analysis services
  • Unblinded support services for Data Safety Monitoring Boards

Pharmaceutical and Clinical Pharmacology Consulting

  • Gap analyses for development program considerations
  • Phase 1 Protocol design
  • Non-compartmental and associated statistical analyses
  • Clinical pharmacology plan development and design
  • Support for meetings with regulatory agencies
  • Response to regulatory requests
  • Performance of End Of Phase 2 dose justification analyses and simulations
  • Synthesis of PK/PD data to guide drug development, regulatory, and commercialization-related decision-making

Regulatory Submissions and Technical Writing

  • Preparation of regulatory briefing packages and submissions
  • Pharmacometric analysis plan and technical report auditing
  • Clinical Study Report preparation
  • Protocol development support
  • Abstract and manuscript drafting and submissions

Pharmacometric Enterprise Support

  • Comprehensive strategic, logistical, and scientific support to establish or strengthen the pharmacometric process
  • Management of integrated project teams staffed with a combination of Cognigen and client scientists
  • Tools and process strategies to improve productivity, consistency, and quality of pharmacometric work products
  • Model Feasibility Assessments
  • Gap analyses of current operating milieu and identification of strategies for improving relationships with upstream and downstream stakeholders

Training Workshops

  • A 3-Day Introductory Workshop in Population PK Data Analysis: A Hands-On Course Using NONMEM®
  • Modeling & Simulation with NONMEM®: A 1- or 2-Day Example-Based Introduction, Including Strategies for Improving the Pharmacometric Enterprise
  • Engineering the Pharmacometrics Enterprise: a two day workshop on strengthening interdisciplinary communications and process infrastructure in model-based drug development