Allow us to feed your Cognigen curiosity.

Who we are.

Cognigen Corporation is a leading provider of comprehensive pharmacometric analysis and support services – including pharmacokinetic and pharmacodynamic (PK/PD) modeling, statistical analyses, clinical trial simulations, and regulatory reporting – focused on dose selection and justification decision support.

Our history.

Cognigen Corporation, based in Buffalo, NY, was co-founded in 1992 by Ted Grasela, PhD, PharmD, President and CEO; Cynthia Walawander, MA, PMP, Executive Vice President and COO; and Jill Fiedler-Kelly, MS, Vice President, Pharmacometric Services and CSO.

Who we've worked with.

Cognigen has partnered with more than 40 global pharmaceutical and biotechnology companies, as well as with the World Health Organization, the Centers for Disease Control and Prevention, and the US Food and Drug Administration. In 2007, 25% of the drugs submitted to the FDA utilized population-based analyses performed by Cognigen.

How we work.

At Cognigen, we use a disciplined approach to model development and strategic thinking, coupled with highly collaborative client relationships, to consistently meet time, quality, and cost requirements for generating rigorous, scientifically valid results.

Our team.

Currently, Cognigen employs 30 full-time professionals, including PK/PD scientists, clinical scientists, statisticians, data managers, programmers, project managers, quality assurance specialists, and administrative and systems support staff.

Our culture.

At Cognigen, we create a working environment that promotes continuous learning and encourages cross-functional team collaboration.

Our attention to detail.

Our experienced data management and programming team is trained in the nuances of pharmacokinetic and pharmacodynamic data, including the Standard for Exchange of Nonclinical Data (SEND) guidelines for animal toxicology studies.

The scientific PK/PD modeling group at Cognigen has extensive experience in challenging research and development scenarios across a wide range of therapeutic areas using a variety of biomarkers and endpoints.

How we think big picture.

At Cognigen, we recognize the downstream implications of translational medicine research and its applications across the lifecycle of development and commercialization.

We possess the strategic insight and experience required to look across the lifecycle of development within and across franchise platforms in order to interpret model-based assessments of comparators and design innovative proof of mechanism and proof of concept studies. We also integrate new knowledge about the pharmacology of compounds and competitors into the design of innovative pre-clinical and clinical study strategies.

Our commitment to technology.

Cognigen has invested more than $5 million over the past ten years in our IT infrastructure, including hardware and software installations and upgrades, security, data warehousing, and communication tools.

We recently introduced Version 3.2 of the PERSPECTIVE Hypertext Data Analysis Mapping software, which provides a visual interpretation of the scientist's analytical thought process and organizes the data, programs, output, and interpretation of analyses in a comprehensive, cohesive manner. Our Knowledge Portals allow global 24/7 communication, discussion, and collaboration of scientific researchers across the Internet using tools such as PERSPECTIVE Maps, discussion boards, web tours, white boards, and distance learning.

How we ensure quality.

Cognigen's Quality Management System has been subjected to 21 major sponsor audits over the last 5 years with no major findings. We are proud of our established reputation with regulatory agencies worldwide for the quality and comprehensiveness of our scientific rationale and deliverables, and we strive to advance the science and engineer systems for model-based drug development.

Our services.

Cognigen Corporation uses the tools of pharmacometrics, embedded in a highly developed enterprise infrastructure, to support decision-making at critical points in drug development. We provide comprehensive pharmacometric analysis and support services emphasizing pharmacokinetic and pharmacodynamic (PK/PD) analyses, statistical modeling, and clinical trial simulations focused on dose selection and justification.

Pharmacometric analyses and support.
• Strategic analysis planning support, including data analysis plan development
• Study design and PK/PD sampling strategy development
• Case report form 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
• Forensic pharmacometrics

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 scientific 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

How to contact us.

Cognigen Corporation
1780 Wehrle Drive, Suite 110
Buffalo, NY 14221-7000 USA

Phone: +1.716.633.3463
Fax: +1.716.633.7404