Certara’s ClinGenuity Named a “Cool Vendor” in Gartner’s 2015 Life Sciences Report

PRINCETON, NJ – Apr. 30, 2015 – Certara®, the global biosimulation technology-enabled drug development consultancy, today announced that its ClinGenuity company has been named a “Cool Vendor” in Gartner, Inc.’s 2015 Life Sciences report1. ClinGenuity was acquired by Synchrogenix, Certara’s regulatory writing company, in January 2015. “We are delighted that Gartner has recognized us,” said … Continued

Do the Right Thing: Ethical Mandates for Clinical Trial Transparency

The history of biomedical research in the United States has long been plagued with ethical problems. Writer Rebecca Skloot details a famous example of this history in her book, “The Immortal Life of Henrietta Lacks.” The non-fiction work recounts the origin of the HeLa cells—derived from the tumor of a Baltimore woman named Henrietta Lacks. … Continued

Connecting Phoenix to Your PK/PD Data Analysis and Reporting Workflow

The pharmaceutical industry is rapidly integrating systems, software, and knowledge across many disciplines. What were once stand-alone systems are now part of a larger workflow that moves research from the bench to the clinic. Pharmacokinetic (PK) and pharmacodynamic (PD) analysis is an essential part of that workflow. Certara’s Phoenix platform enables users to seamlessly integrate … Continued

Month 2 Culture Status and Treatment Duration as Predictors of Recurrence in Pulmonary Tuberculosis: Model Validation and Update

New regimens capable of shortening tuberculosis treatment without increasing the risk of recurrence are urgently needed. A 2013 meta-regression analysis, using data from trials published from 1973 to 1997 involving 7793 patients, identified 2-month sputum culture status and treatment duration as independent predictors of recurrence. The resulting model predicted that if a new 4-month regimen … Continued

Synchrogenix & CISCRP Partner to Help Biopharm Companies Meet Clinical Data Transparency Mandates

The Center for Information and Study on Clinical Research Participation (CISCRP) and Synchrogenix, Certara’s regulatory writing consultancy, are collaborating to develop lay summaries of clinical trials for the general public PRINCETON, NJ – April 23, 2015 – Certara®, the global biosimulation technology-enabled drug development consultancy and the nonprofit Center for Information and Study of Clinical … Continued

Pediatric Drug Dosing: Tackling Big Problems for Little Patients

The challenges and complexities of pediatric drug development are well recognized. Pharmacometric modeling and simulation (M&S) leverages prior knowledge to support pediatric drug dosing, trial design and regulatory writing for submissions. As the benefits of pharmacometrics for drug development and regulatory decision-making become increasingly well documented, the FDA has challenged the industry to more rigorously apply … Continued

Modeling and Simulation to Support Pediatric Drug Development

Conducting clinical drug trials in children poses numerous practical and ethical challenges. The benefits of using modeling and simulation for pediatrics include an increased likelihood of success, a reduced trial duration, and minimizing blood draws. In this presentation, Dr. JF Marier discussed how to use modeling and simulation to address the challenges of pediatric drug … Continued

Population Analysis of Complex Multidimensional Responses Using Phoenix NLME

During this webinar, Dr. Serge Guzy demonstrated how Phoenix NLME’s unique interface facilitates a whole new way of thinking about Pop PK/PD that is well-suited to both beginning and advanced modelers. He also highlighted Phoenix NLME’s robust optimization engines, including the recent updates to the QRPEM engine. The webinar showed how easy Phoenix NLME makes … Continued