Certara
Software & Data
Princeton, New Jersey

Overall Rank: 23
Category: Software & Data
Category Rank: 7

Awards:

  • Top HealthTech Company of 2022

Profile

Certara accelerates medicines using proprietary biosimulation software, technology, and services to transform traditional drug discovery and development. As a global leader in biosimulation, Certara serves more than 2,000 biopharmaceutical companies, academic institutions, and regulatory agencies across 62 countries.


Seventeen global regulatory agencies, including the U.S. FDA, Japan’s Pharmaceuticals and Medical Devices Agency, and China’s National Medical Products Administration, have adopted Certara’s Phoenix™ PK/PD software and/or Simcyp™ PBPK Simulator. The Company’s COVID-19 Vaccine Model received both an R&D 100 Award and Edison Award in the past year. In October 2021, Certara acquired Pinnacle 21, a leading provider of SaaS solutions for clinical data fitness, regulatory compliance, and submission readiness.


With its software and global team of nearly 1,200 employees, Certara advances confident decision-making throughout the biopharma R&D lifecycle to help reduce time, lower cost, and improve outcomes for patients. The company’s customers who use its software and services have received over 90% of new drug approvals by the FDA since 2014, excluding diagnostics.


Visit www.certara.com


Key Products

Simcyp PBPK Simulator


The Simcyp Simulator is the pharmaceutical industry’s most sophisticated physiologically based pharmacokinetics (PBPK) platform for determining first-in-human dosing, optimizing clinical study design, evaluating new drug formulations, setting the dose in untested populations, performing virtual bioequivalence analyses, and predicting drug-drug interactions (DDIs). Simcyp is being applied to small molecules, biologics, ADCs, generics, and new modality drugs.


Phoenix WinNonlin


PK/PD and non-compartmental analyses can be time consuming, requiring detailed attention to every step from data preparation to report generation. Phoenix WinNonlin™’s integrated tools for data processing, graphing & charting, report generation, and compliance create an efficient, all-in-one collaboration workbench.


GlobalSubmit™ eCTD Software


Whether you are experienced or new to the regulatory submission process, the risk of rejection of your electronic common technical document (eCTD) submissions cannot be taken lightly, especially given the changing and growing complexity of the regulatory environment. Not to mention, differences in eCTD submission criteria per region, managing the entire documentation lifecycle, and meeting your organization’s goals on expediting your release to market.


Phoenix™ Pharmacokinetic and Pharmacodynamic (PK/PD) Platform


The Phoenix Platform also features population PK/PD (popPK) modeling with Phoenix NLME and Level A correlation via the Phoenix IVIVC Toolkit, Validation Suites provide fast and easy software validation in under 30 minutes.Furthermore, the platform also includes tools for creating turnkey visualizations and submission-ready reporting.


Pinnacle 21 Enterprise CDISC Software


Pinnacle 21 is a global leader in software for preparing clinical trial data for regulatory submission. Twenty-two of the largest 25 global biopharmaceutical companies trust Pinnacle 21 Enterprise. It is the same platform used by the US FDA and Japan’s PMDA to review a submission’s data quality, CDISC compliance, and fitness for use.


Quantitative Systems Pharmacology (QSP) Software


QSP has enormous potential to improve biopharmaceutical R&D and inform decision-making across the drug development process. QSP combines computational modeling and experimental data to examine the relationships between a drug, the biological system, and the disease process. With the ability to leverage vast amounts of biological and pharmacological data, QSP enables the understanding of disease pathophysiology, to identify and test therapeutic strategies in virtual trials with virtual patients.


D360 Scientific Informatics Platform


D360™ is the industry-leading scientific data informatics platform used globally by over 6,000 discovery research scientists in small molecule and biologics discovery and pre-clinical safety. It delivers self-service data access and an integrated analysis and visualization solution.


The BaseCase™ Platform


Developing interactive and easy-to-use stakeholder engagement content for market access, medical affairs, and sales field teams is a time-consuming, expensive, and often decentralized process. BaseCase is a “no-code” platform that enables you to visualize large complex datasets and economic models, clearly demonstrating the value of your products to key decision-makers.


GlobalSubmit™ eCTD Software


With Certara’s GlobalSubmit™ eCTD submissions management software, you’ll provide your regulatory team the tools they need to efficiently publish, validate, and review your eCTD submissions. This means you can eliminate risk and avoid unnecessary steps with a simplified eCTD submission process that supports your regulatory team as they race to meet deadlines and deliver treatments to patients.


Customer Insights

“Forget about presenting your product’s value messages through confusing spreadsheets or static slides. BaseCase provides you with a wide range of possibilities for engaging interactive and customizable apps. Easy to develop, update and track.” – Health Economics & Outcome Research Manager


 


“One of the challenges in making important value messages relevant is an effective communication to our customers, both internal and external. The BaseCase platform and its visual presentation boils the components down to the essential elements that strike the right chord to make the messages come alive in the customer’s mind.” – Senior Analyst


 


“The Medical Device industry faces mounting challenges in a changing reimbursement and contracting landscape, and the need to present economic information to hospital administrators has increased exponentially. The BaseCase platform plays a key role for us to accomplish that goal.” – Director, Global Market Access & Health Economics


 


“For a small team that has limited time to compile and double check a submission, GlobalSubmit is a really good platform because it is all integrated, including crosscheck and validate. So, you know when you generate the submission that it is compliant, and you don’t need another tool for validation” – Jessica Pung, MS, RAC, Associate Director of Regulatory Operations, Prelude Therapeutics