01. Discover
About Cognigen, a Simulations Plus division

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 our scientists and staff’s professional growth and development.

A man with gray hair, beard, and glasses reflects wisdom in a Simulations Plus blue shirt.
A man with gray hair, beard, and glasses reflects wisdom in a Simulations Plus blue shirt.
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 ensure 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.

02. Explore
Cognigen® 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.

Cognigen® Services includes business marketing consulting services for pharmaceutical and healthcare industries; electronic storage of data; and pharmaceutical research in the fields of pharmacokinetics, pharmacodynamics, pharmaceutical economics, and pharmaceutical outcomes.

Learn more about Cognigen® Services below:

Model based Drug Development Strategies

PK/PD Modeling and Simulation

PK/PD Support

A confident professional engaged in modeling and simulation using the sophisticated tools provided by Simulations Plus, Inc.
A confident professional engaged in modeling and simulation using the sophisticated tools provided by Simulations Plus, Inc.
View Cognigen Workshops
learn more
Download the NCA Flyer
learn more
03. Testimonials
What our customers say

“Thanks so much for your super-responsiveness!!”

Sr Clinical Research Scientist

“You guys are the best. Always two steps ahead of me!!”

Sr Clinical Research Scientist

“Thanks so much for joining the call. I think your feedback was extremely valuable, and gave fresh perspective and ideas for the team. Really appreciate your time and expertise, especially with a project that’s been particularly perplexing to our team.”

Sr Clinical Research Scientist

“Considering that this was an atypical project into which you were introduced at the last minute with less-than-ideal datasets, I’m actually very impressed with the outcomes…”

Sr Clinical Research Scientist

“Simulations Plus had to bypass several key planning steps in order to complete a most unpredictable deliverable under a very aggressive timeline. Still, your team’s “all hands-on deck” approach brought us to what I would consider the best position we could possibly make for ourselves on this program, and the whip cream on top is a trusted team of consultants with the exact background we need to field future questions from FDA. I couldn’t ask for more.”

Sr Clinical Research Scientist

“It has been an absolute pleasure working with the team – your efforts to build population and absorption models for our program with a mass of random data and extremely aggressive timelines were nothing short of impressive–they’re a testament to your high standards for quality and customer service.”

Sr Clinical Research Scientist

“Your analysis is very clear and most highly appreciated, as well as your exceptional responsiveness, and thorough work on the valuation of the hypothesis.”

Senior Vice President, Clinical Development

“We were very impressed with the details and clear explanations provided in the Statistical Analysis Plan.”

Top 10 Pharma

“I just noticed the discount offered due to the non-profit status of our organization and I wanted to say how much we appreciate this. Thank you for extending this discount to us.”

Non-Profit Organization
04. News
Latest research by Cognigen
view all publications