Certara Professional Courses and Certifications

June-July 2025 Cost - $550 (Academia $275, Africa/India $150) Certification Course Description In this course you will learn and get certified on the theory and application of non-compartmental analysis (NCA).  NCA is used to characterize the kinetics of a compound without assuming a specific compartmental model.   You will learn NCA methodology, how to perform NCA using Phoenix WinNonlin software, and how to interpret resulting pharmacokinetic parameters.   This course is a comprehensive review of noncompartmental analysis of pharmacokinetic data and will cover the basics through the most complex areas of noncompartmental analysis.  Upon successful completion of this course, you will receive an e-badge as an NCA Analyst using Phoenix WinNonlin.  This certification is valid for 3 years. Pricing $550 (Academia $275, Africa/India $150) Users requesting an Academic membership will only be accepted with proof of academic status by using an active academic email address. Users from Africa/India will need to provide Certara University with a copy of their government issued proof of residency.  If an email address fails to meet that standard, the individual will be notified and will not be given access to the requested membership type. Course Format, Language and Dates This course format is a combination of recorded and live content.  Each week there will be video lessons to watch that introduce the concepts and practical applications for the week's topics.  We will then meet for an online 2-hour live session (under the guidance of an expert Phoenix instructor) in which you will work cooperatively on hands-on exercises done in small groups.  The large-group portion of these sessions will be recorded, with the exception of the work done in breakout groups. The course will be available for you to access for three months following the final live session.  If you want longer access, you can purchase This course will be delivered in English. Live Sessions There will be six two-hour live Zoom sessions.  Attending the live sessions in person is highly recommended.  In these sessions we will briefly review the key points from the recordings, and then play a game to review the material.  You will then work in small groups on an exercise in Phoenix.  We will meet in the big group to discuss the results.  We will record sessions (except for breakout groups) and post the recordings for those who are unable to attend live.  You will have access to the recordings for 3 months following the last session of the course.  The schedule for live sessions is: Session Date Time Duration Time Zone Presenter Host Session 1 (Tuesday) 3 June 2025 10 AM 2 hours New York (GMT-4) TBA TBA Session 2 (Tuesday) 10 June 2025 10 AM 2 hours New York (GMT-4) TBA TBA Session 3 (Tuesday) 17 June 2025 10 AM 2 hours New York (GMT-4) TBA TBA Session 4 (Tuesday) 24 June 2025 10 AM 2 hours New York (GMT-4) TBA TBA Session 5 (Tuesday) 8 July 2025* 10 AM 2 hours New York (GMT-4) TBA TBA Session 6 (Tuesday) 15 July 2025 10 AM 2 hours New York (GMT-4) TBA TBA * We will take a week off for the July 4 holiday in the US. Office Hour Sessions Once a week (on Friday) we will meet in a one-hour Zoom session to allow for open question time on any relevant topic.  Please attend live and bring your questions. Session Date Time Duration Time Zone Instructors Hands-on Exercise 1 (Friday) 6 June 2025 11 AM 1 hour New York (GMT-4) TBA Hands-on Exercise 2 (Friday) 13 June 2025 11 AM 1 hour New York (GMT-4) TBA Hands-on Exercise 3 (Friday) 20 June 2025 11 AM 1 hour New York (GMT-4) TBA Hands-on Exercise 4 (Friday) 27 June 2025 11 AM 1 hour New York (GMT-4) TBA Hands-on Exercise 5 (Friday) 11 July 2025* 11 AM 1 hour New York (GMT-4) TBA * We will take a week off for the July 4 holiday in the US. Certification This course includes a certification exam.  To obtain credit for this course and earn a Certara Certification as an NCA Analyst using Phoenix WinNonlin either version 8.4 or 8.5, candidates need to earn a passing score on the exam.  The exam validates proficiency and competence with non-compartmental (NCA) pharmacokinetic (PK) analysis using Phoenix WinNonlin, with version 8.4 or 8.5. A certified NCA analyst can process data, perform exploratory data analysis, calculate NCA parameters, and report results for typical PK study designs in pre-clinical and clinical trials.   Exam Details Software:  There is no requirement to have the Phoenix WinNonlin™ software installed to take the certification exam.  The exam has interactive questions embedded that simulate the software.  Those interactive questions are based on Phoenix WinNonlin 8.4 or 8.5. Grading: To successfully earn the NCA Analyst certification, a minimum passing score of 75% must be achieved on both parts of the online accreditation exam. Each registration includes 2 attempts at passing the test. The exam tests 80-90 questions that cover theoretical knowledge of NCA analysis on different types of study designs, and a practical section that evaluates software proficiency by performing tests related to NCA analysis, data processing, and reporting.  Time Limit:  The exam is divided into 2 parts. There is a total time limit of 1 hr and 45 min to complete part 1 and 75 minutes to complete part 2 of the exam.  The clock starts counting when the user clicks on 'Start Exam' in each part. Exam Content:   Successful candidates should understand fundamentals of Pharmacokinetics, NCA theory, typical study designs that are often analyzed with NCA, and hands-on experience with Phoenix WinNonlin.  Certification topics include: Basic Theory of PK and NCA Phoenix Interface Exploratory Data Analysis - Data Tools and Plots Performing NCA in Phoenix Processing NCA results Non-Parametric Superposition Study Designs Prerequisites and Time Commitment This course requires basic understanding of pharmacokinetics (recommended background: (103-OD) Fundamentals of Pharmacokinetics).  Students are expected to be able to commit 5 hours a week to attend sessions and complete assignments. Software Phoenix WinNonlinTM Participants are required to have a current license of Phoenix.  A training license for the duration of the course can be purchased for an additional fee by contacting us. Read more

July-September 2025 Cost - $550 (Academia $275, Africa/India $150) Certification Course Description This course will teach you the theory and application of compartmental modeling, using the Phoenix Model. You will learn how to create Maximum Likelihood PK models using Phoenix WinNonlin software. You will evaluate competing structural models and choose the best residual error model for the data.  In addition to using the built-in "library" models, you will learn to use the Graphical Model Editor to customize PK models.  You will learn how to use simulations to make decisions, such as evaluating different dosing regimens with respect to safety and efficacy.  Upon successful completion of this course, you will receive an e-badge as a PK/PD Modeler using Phoenix WinNonlin.  This certification is valid for 3 years. Pricing Cost - $550 (Academia $275, Africa/India $150) Users requesting an Academic membership will only be accepted with proof of academic status by using an active academic email address. Users from Africa/India will need to provide Certara University with a copy of their government issued proof of residency.  If an email address fails to meet that standard, the individual will be notified and will not be given access to the requested membership type. Course Format, Language and Dates This course is a ‘Live on-line classroom’ which means that the course is delivered virtually by an expert Phoenix instructor at pre-specified times.  This format provides the benefit of the classroom setting, with real-time interaction with the instructor but without the travel.  Although live attending is encouraged, recordings of the sessions are available to participants during the length of the course.  This course will be delivered in English. Lecture/Demo Sessions Live Zoom sessions will occur in July, August and September 2025.  There will be six two-hour lecture/demo sessions.  Lecture/Demo sessions are on Tuesdays at 10 AM New York (GMT-4), starting 29 July and finishing on 2 September.  We will record sessions and post the recordings for those who are unable to attend live.  You will have access to the recordings for 3 months following the last session of the course. Self-Paced Exercises There are five self-paced exercises in the course that guide you through exploratory data analysis, data preparation, and noncompartmental data analysis.  You do not need to run Phoenix to do the self-paced exercises, because everything is contained in the module.  Each practice exercise contains a quiz that you must pass with at least a 60% score, although you can repeat each quiz as many times as you need to pass it.  Hands-on Exercise Sessions There are also five weekly "Hands-on Exercise" Zoom sessions that give you the opportunity to carry out the same analysis as in that week's "Self-Paced Exercise", working collectively in Phoenix.  You will be divided into small groups, and will work together on the exercise.  At least one in each group will need to have Phoenix running on their computer and have an active WinNonlin license. Hands On Exercise Session Option A is offered at times most convenient for participants in the Americas, Europe, and Africa.  They are on Fridays at 11 AM New York (GMT-4).  Hands On Exercise Session Option B is offered at times most convenient for participants in Asia/Pacific.  They are on Tuesdays at 2 PM Brisbane (GMT+10).  (FYI, 2 PM Tuesday in Brisbane is late Monday evening in New York.) Certification Exam This course includes a certification exam.  To obtain credit for this course and earn a Certara Certification as a PK/PD Modeler using Phoenix WinNonlin version 8.4 or 8.5, candidates need to earn a passing score on the exam.  The exam validates proficiency and competence with Maximum Likelihood Models in Phoenix WinNonlin. Exam Details Software:  There is no requirement to have the Phoenix WinNonlin™ software installed to take the exam.  The exam has interactive questions embedded that simulate the software.  Those interactive questions are based on Phoenix WinNonlin 8.4 or 8.5. Grading: To successfully earn the PK/PD Modeler certification, a minimum passing score of 75% must be achieved on both parts of the online accreditation exam. Each registration includes 2 attempts at passing each part of the test. The exam tests 80-90 questions that cover theoretical knowledge of PK/PD modeling, and a practical section that evaluates software proficiency by performing tests related to model building, evaluating model adequacy, comparing models, conducting simulations and customizing models using the Graphical Model Editor.  Time Limit:  The exam is divided into 2 parts. There is a time limit of 1hr 45min to complete part 1, and 1hr 15min to complete part 2 of the exam.  The clock starts counting when the user clicks on 'Start Exam' in each part. Exam Content:   Successful candidates should know both theory and practice of PK/PD modeling, from model building to simulation.  Certification topics include: Theory and Practice of PK/PD Modeling Determining Initial Estimates Residual Error Evaluate Model Adequacy and Compare Models Data Manipulation (Phoenix Data Tools) Customizing Models (Graphical Model Editor) Conducting Simulations Reporting Modeling Results Prerequisites and Time Commitment There are no mandatory pre-requisites for this course although familiarity with the Phoenix platform and NCA is highly recommended as well as a basic understanding of pharmacokinetics is preferred.  Courses that cover these topics are: (122-LIVE-CERT) Phoenix WinNonlin (Part 1) NCA Certification Course (103-OD) Fundamentals of Pharmacokinetics Students are expected to be able to commit 5 hrs a week to attend sessions and complete assignments. Software Phoenix WinNonlinTM Participants are expected to have a current license to Phoenix WinNonlin.  If a 60-day software license is needed one can be provided for an additional fee.  Contact us if you want to order a license. Read more

September-October 2025 Cost - $550 (Academia $275, Africa/India $150) Certification Course Description The objective of this course is to train Phoenix WinNonlin users how to perform population PK using Phoenix NLME. Population PK/PD modeling is being used increasingly in regulatory submissions.  Population PK modeling can handle sparse data and also data combined from several studies.   The population approach estimates the variability between subjects in the PK parameters and can help you understand potential sources of PK variability. Through a series of practical exercises, learners will create population PK models, add covariates to models to help explain and quantify individual variation, and validate their models using bootstrap and VPC. Learners will become familiar with the theory necessary to make effective use of population modeling. Pricing Cost - $550 (Academia $275, Africa/India $150) Users requesting an Academic membership will only be accepted with proof of academic status by using an active academic email address. Users from Africa/India will need to provide Certara University with a copy of their government issued proof of residency.  If an email address fails to meet that standard, the individual will be notified and will not be given access to the requested membership type. Course Format, Language and Dates This course format is as a ‘Live on-line classroom’ which means that the course is delivered virtually by an expert Phoenix instructor at pre-specified times.  This format provides the benefit of the classroom setting, with real-time interaction with the instructor but without the travel.  Although live attending is encouraged, recordings of the sessions are available to participants during the length of the course. You will have access to the recordings for 3 months following the last session of the course. This course will be delivered in English. Lecture/Demo Sessions Live Zoom sessions will occur in September and October, 2025.  There will be six two-hour lecture/demo sessions.  Lecture/Demo sessions are on Tuesdays at 10 AM New York (GMT-4), starting 16 September and finishing on 21 October.  We will record sessions and post the recordings for those who are unable to attend live.  You will have access to the recordings for 3 months following the last session of the course. Self-Paced Exercises There are five self-paced exercises in the course that guide you through exploratory data analysis, data preparation, and noncompartmental data analysis.  You do not need to run Phoenix to do the self-paced exercises, because everything is contained in the module.  Each practice exercise contains a quiz that you must pass with at least a 60% score, although you can repeat each quiz as many times as you need to pass it.  Hands-on Exercise Sessions There are also five weekly "Hands-on Exercise" Zoom sessions that give you the opportunity to carry out the same analysis as in that week's "Self-Paced Exercise", working collectively in Phoenix.  You will be divided into small groups, and will work together on the exercise.  At least one in each group will need to have Phoenix running on their computer and have an active WinNonlin license. Hands On Exercise Session Option A is offered at times most convenient for participants in the Americas, Europe, and Africa.  They are on Fridays at 11 AM New York (GMT-4).  Hands On Exercise Session Option B is offered at times most convenient for participants in Asia/Pacific.  They are on Tuesdays at 2 PM Brisbane (GMT+10).  (FYI, 2 PM Tuesday in Brisbane is late Monday evening in New York.) Certification Exam This course includes a certification exam.  To obtain credit for this course and earn a Certara Certification as a PK/PD Modeler using Phoenix WinNonlin version 8.4 or 8.5, candidates need to earn a passing score on the exam.  The exam validates proficiency and competence with Maximum Likelihood Models in Phoenix WinNonlin. Exam Details Software:  There is no requirement to have the Phoenix NLME™ software installed to take the exam.  The exam has interactive questions embedded that simulate the software.  Those interactive questions are based on Phoenix NLME 8.4 or 8.5. Grading: To successfully earn the Population Modeler certification, a minimum passing score of 75% must be achieved on both parts of the online accreditation exam. Each registration includes 2 attempts at passing each part of the test. The exam tests 80-90 questions that cover theoretical knowledge of population modeling, and a practical section that evaluates software proficiency with population models in Phoenix NLME. Time Limit:  The exam is divided into 2 parts. There is a time limit of 1hr 45min to complete part 1, and 1hr 15min to complete part 2 of the exam.  The clock starts counting when the user clicks on 'Start Exam' in each part. Exam Content:   Successful candidates should be able to use Phoenix NLME to create population models, including covariate analysis, covariance analysis, model validation, and simulation.  Exam topics include: Population PK Theory Data Preparation Exploratory Data Analysis Model Development Covariate Models Covariance Models Model Comparisons Model Validation (VPC and Bootstrap) Reporting Population Model Results Prerequisites and Time Commitment Fundamental knowledge of PK/PD concepts including basic compartmental models.  Familiarity with the functionality of Phoenix WinNonlin software.  Recommended background courses include: (103-OD) Fundamentals of Pharmacokinetics either (122-LIVE-CERT) or (122-OD-CERT) Phoenix WinNonlin (Part 1) NCA Certification Course either (123-LIVE-CERT) or (123-OD-CERT) Phoenix WinNonlin (Part 2) PK/PD Modeling Certification Course Students are expected to be able to commit 5 hrs a week to attend sessions and complete assignments. Software Phoenix WinNonlin and NLME Participants are expected to have current licenses for both Phoenix WinNonlin and Phoenix NLME.  If a 60-day software license is needed one can be provided for an additional fee.  Contact us if you want to order a license.   Read more

Cost - $1000 (Academia $500, Africa/India $250) Course Description This course focuses on PK/PD individual data analysis using PK compartmental models and PK/PD models. The intermediate PK/PD course will teach you how to set the models in Phoenix WinNonlin and how to interpret the results. The course will guide you through the process of selecting the best model and how to make predictions with the final model. Model selection is performed selecting library models, building the model graphically or coding the model in PML language. Course topics include nonlinear modelling theory, fitting PK data, effect compartment PK/PD models, direct and indirect response PK/PD models, analyzing binary data, designing better studies and combining data among subjects. A high level overview of population methods is provided (Note that population methods are covered in detail in courses that use Phoenix NLME). The concepts of each topic are explained in detail via instructional videos. Exercises are introduced and you are expected to practice concepts learned by performing the exercises on your own. Step by step solution videos are also provided to check your work. Your understanding of the concepts discussed is tested via short quizzes throughout the course. If you are an academic user, please contact us so we can update your account profile to give you access to academic pricing.  Note that you must register with an email address that is associated with an academic institution to get academic pricing. If you are located in Africa or India, please contact us so we can so we can update your account profile to give you access to the Africa/India pricing.  You will need to provide proof that you are physically located in India to get the pricing. Software Used Phoenix WinNonlin™  A temporary (30-day) license is provided to subscribers of this course.  When you are ready to start the practice exercises in this course, contact us to request your license. Accessing the Course After registering for this course, login to www.certarauniversity.com and see the course under the Catalog Section ‘My Courses’.  You will have access to this course for a period of 3 years after the purchase. The purchase is for a single seat in the course. No sharing the login between different individuals is allowed. Additional seats must be purchased if more than one person wishes to take the training course. Course Length:  The course provides approximately 16 hours of video instruction which includes a practical component that you can do at your own pace. It is expected to take participants about 40+ hours to complete, including time to perform the tasks in Phoenix. Prerequisites It is assumed that learners have familiarity with NCA and individual PK/PD modeling, a good background in pharmacokinetics and pharmacodynamics, and prior experience with the Phoenix is recommended. Participants should also be able to perform the tasks in the following Certara University courses: Introduction to Phoenix WinNonlin (Part 1) - NCA  (122-OD-CERT or 122-LIVE-CERT) Introduction to Phoenix WinNonlin (Part 2) - Modeling (123-OD-CERT or 123-LIVE-CERT) Instructor Ana Henry has extensive experience in a variety of roles in the Pharmaceutical industry. Most recently she acted as product manager for the complete suite of Certara Pharsight desktop products, personally leading the development of Phoenix®, the industry’s premier PK/PD software platform. Currently, she is with Certara University’s Scientific Training and Education Department, tasked with training and content development of on-demand courses. Ana has extensive experience in software demonstration and training and is adept at offering technical expertise and evaluation of software products. She has trained and provided support for Phoenix WinNonlin, Phoenix Connect, Phoenix NLME, Pharsight Knowledgebase Suite, AutoPilot, PKS Reporter, Trial Simulator, and PK/PD methodology courses. Prior to Certara, Ana worked in the pharmaceutical industry as a biostatistician and a pharmacokineticist, designing, analyzing and reporting on clinical studies. Ana is also a regular guest speaker in the graduate PK/PD course at the University of Colorado Skaggs School of Pharmacy and Pharmaceutical Sciences. Read more

Bundle Cost - $900 ($450 Academia, $225 Africa/India) This bundle is recommended for scientists who want to earn the Certara NCA certification and who are new to pharmacokinetics. Those who successfully complete the certification course will earn the following certification: Certara Certified NCA Analyst using Phoenix WinNonlin Version 8.3 This bundle includes three courses: two conceptual courses (delivered in e-learning format) and one certification course (delivered live online). The certification exams are included in the certification courses.  If purchased separately, the three courses would cost $1148, so you can save $248 by purchasing the bundle. Courses Included (see Content Tab for details) (103-OD) Fundamentals of Pharmacokinetics [Conceptual Course] | e-learning format (105-OD) Noncompartmental Data Analysis [Conceptual Course] | e-learning format (122-LIVE-CERT) Phoenix WinNonlin (Part 1) NCA Certification Course | live online format Read more

Bundle Cost - $1400 ($700 Academia, $350 Africa/India) This bundle is recommended for scientists who want to earn the certifications for both NCA and PK/PD modeling, and who are new to pharmacokinetics. Those who successfully complete the certification courses will earn the following certifications: Certara Certified NCA Analyst using Phoenix WinNonlin Version 8.3 Certara Certified PK/PD Modeler using Phoenix WinNonlin 8.4 This bundle includes four courses: two conceptual courses (delivered in e-learning format) and two certification courses (delivered live online). The certification exams are included in the certification courses.  If purchased separately, the four courses would cost $1698, so you can save $298 by purchasing the bundle.  Courses Included (see Content Tab for details) (103-OD) Fundamentals of Pharmacokinetics [Conceptual Course] | e-learning (105-OD) Noncompartmental Data Analysis [Conceptual Course] | e-learning (122-LIVE-CERT) Phoenix WinNonlin (Part 1) NCA Certification Course | live online (123-LIVE-CERT) Phoenix WinNonlin (Part 2) PK/PD Modeling Certification Course | live online Read more