Cognigen

Providing strategic pharmacology and pharmacometric consulting services, PK/PD model development with NONMEM, clinical trial simulations, exposure-response evaluations, dose justification strategies and related data management services.

About Cognigen, a Simulations Plus company

Our vision is to advance the science and engineer the systems for model-based drug development.

Our mission has two parts. First, to help our clients understand the determinants of safety and efficacy of new medicines in order to:

  • Increase stakeholder confidence at decision-making milestones,
  • Improve the chances for success with innovative therapies, and
  • Enhance the value of new medicines for patients and providers.

And second, to provide a challenging and rewarding work environment for the professional growth and development of our scientists and staff.

Why Cognigen?

Are there other companies that claim to do what we do? Yes.

Can they match our expertise and credibility? No way. Here’s why.

  • We have extensive experience in dealing with the critical issues of pharmacometric analysis and decision support.
  • We have successfully supported PK/PD-based development programs in nearly all therapeutic categories for both large and small Pharma.
  • Our approach to client support and communication is unique as evidenced by our repeat business.
  • Our infrastructure has been subject to rigorous client audits and is recognized as one of our major strengths.
  • Our deliverables are comprehensive and recognized by regulatory agencies for their credibility as a basis for decision-making.

Need more persuading? Just contact us, and we’ll be happy to answer any specific questions you may have.

Working With Us

As your partner, we’ll pull out all the stops to deliver the results you need. How exactly do we do that? We’re glad you asked.

  • We perform innovative analyses that result in new findings and shed light on difficult challenges.
  • Then we synthesize these findings with existing knowledge to place results into an appropriate context for decision-making.
  • Finally, we overcome time constraints and deliver results to meet aggressive developmental milestones.

But we don’t stop there – not even close. We also hold a firm belief that our relationship with you is just as important as the analytical work. So don’t expect us to disappear with your data and return with “the answer.” In our experience, successful projects almost always involve a high level of collaboration. Working together allows us to complete analyses as quickly as possible, integrate findings into the submission package story, and ensures both you and the regulators understand what we did, why we did it, and what the implications of our work may be.

Like what you hear? Then get in touch and let’s get started.

Our Software

Our team has systematically examined the requirements, constraints, and standard practice across pharmacometrics, data management, administrative support, and IT departments in order to build critical functionality in an elegant framework to support pharmacometric data and scientific workflows. Click on the software title in the right hand column to learn more about KIWI.

Our Services

Increase your odds through the science of pharmacokinetics and pharmacodynamics.  Our results will arm you with the knowledge to successfully achieve critical milestones, the credibility to withstand regulatory scrutiny, and the confidence you will avoid costly surprises down the road. Learn more below: