About Our Software


As the industry leader in quantitative drug development and regulatory science, Certara has pioneered a range of software technologies and platforms to inform and advance the process of bringing drugs to patients. Combining ‘best-of-breed’ legacy brands such as Pharsight®, Simcyp®, Phoenix®, WinNonlin™, Tripos™, Global Submit™, and BaseCase™, Certara’s software is leveraged across the pharma life cycle.

Pharmacologists, biologists, toxicologists, biostatisticians, pre-clinical scientists, chemists, geneticists, and other scientists use our software to advise key safety, efficacy and efficiency decisions. Target identification and optimization, first-in human dose and dosing regimen, translational science, trial design, target validation, compound triaging, comparative efficacy, regulatory submittal, and market access/pricing support are informed by Certara’s growing portfolio of technologies.

Drug Development Regulatory Submissions
and Disclosure
Evidence and Access

Drug Development

Developing new drug therapies and providing them to patients is a complex process. At Certara, we have developed and brought together a unique set of disciplines and technologies to address those underlying factors. More than 1,700 pharma/biotech companies, regulatory institutions, and academic/research entities leverage Certara’s software. Most important, >90 % of all novel FDA approvals have used Certara’s software in the development process, most notably our Phoenix pharmacometrics and Simcyp PBPK platforms. Certara’s software provides benefit across the drug development continuum, from discovery through market access.

Pharmacokinetic/
pharmacodynamic
(PK/PD) modeling

Population-based
pharmacokinetic modeling
and simulation

Data Analytics
& Informatics

Phoenix WinNonlin

Phoenix NLME

Phoenix IVIVC Toolkit

Pirana

PK Assist

PK Submit

Trial Simulator

Cardiac Safety Simulator

Quantitative Systems
Pharmacology (QSP)

Quantitative Systems
Toxicology and Safety (QSTS)

Simcyp PBPK Simulator

SIVA

Certara Integral

CODeX

D360

D360 Pre Clinical
Safety Store

 

Regulatory Submissions and Disclosure

The pressure to digitize and disclose clinical information, combined with the ever-growing volume and complexity of data generated in the pharmaceutical development process, have propelled the industry to adopt technology that delivers speed and quality to regulatory submissions.  Certara’s regulatory software platforms have been used with hundreds of global submissions, incorporating proven machine learning and artificial intelligence approaches for writing and content reuse, electronic publishing and documentation, and transparency and disclosure of clinical information.

Global Submit
Publishing 

Global Submit
Validation 

Global Submit
Review

ClinGenuity
Redaction
Management

Synchrogenix
Content

Creation Tools

 

Evidence and Access

Demonstrating value and the ROI of a new therapy is both an art and a science. Certara’s BaseCase software platform facilitates an all-in-one customer engagement approach to clearly make the value case for that therapy. From value communication tools and calculators, real-world evidence visualizations, KAM and sales training toolkits to innovative pricing tools, e-detailing aids, data tracking, and global HTA and interactive value dossier trackers, BaseCase cloud-based software is the most versatile product of its kind.

BaseCase
for Pharma

BaseCase
for MedTech

BaseCase
Portal

BaseCase
Toolkits

 

Certara’s software development team follows a roadmap that systematically delivers new technology based on our interactions with clients, software users, academic partners, and regulatory reviewers. In addition, our development team can provide a range of “fit-for-purpose” services to meet specific company requirements.

To Learn More or to Request a Demo,