Brazilian Health Surveillance Agency, ANVISA, Adopts Certara’s Phoenix Software for Drug Regulatory Reviews
PRINCETON, NJ-Jan. 17, 2018-Certara®, the global leader in model-informed drug development and regulatory science, today announced that the Brazilian National Health Surveillance Agency – ANVISA (Agência Nacional de Vigilância Sanitária) – is now also employing Certara’s Phoenix® WinNonlin® software for reviewing drug regulatory submissions. “Phoenix WinNonlin is used by many Brazilian organizations to determine bioequivalence. It is recognized for increasing productivity, improving workflows, and ensuring high accuracy for studies of drug action in the human body,” said Ellen Leinfuss, Certara’s Chief Commercial Officer. “In addition, ANVISA’s adoption of this Phoenix software will help to ensure that reviewed studies follow good bioequivalence practices. Furthermore, analysis results generated by the organizations conducting bioequivalence studies and ANVISA will be completely compatible.” Phoenix WinNonlin is considered the industry standard for non-compartmental analysis, and pharmacokinetic/pharmacodynamic, and toxicokinetic modeling. It was purpose-built to automate and expedite many of the analysis steps required during the drug regulatory review process. Phoenix WinNonlin provides integrated data processing, post-analysis processing, table creation, and graphics tools for use in drug development projects. In fact, Phoenix WinNonlin is used by more than 6,000 scientists at more than 1,500 institutions in 60 countries. Those organizations include the top pharmaceutical companies, scores of smaller biopharmaceutical companies, contract research organizations, and about 200 academic institutions. Phoenix is also employed by many global regulatory agencies to evaluate drug submissions. They include the China Food and Drug Administration, European Medicines Agency, Japan Pharmaceuticals and Medical Devices Agency, UK Medicines and Healthcare Products Regulatory Agency, and 11 divisions of the US Food and Drug Administration. About Certara Certara is a leading decision support technology and consulting organization committed to optimizing drug development and improving health outcomes. Certara’s solutions, which span drug discovery through patient care, use the most scientifically-advanced modeling and simulation technologies and regulatory strategies to increase the probability of regulatory and commercial success. Its clients include hundreds of global biopharmaceutical companies, leading academic institutions, and key regulatory agencies. For more information, visit www.certara.com.
FDA Approves Nipocalimab for the Treatment of Generalized Myasthenia Gravis
April 30th 2025Approval is based on results from the pivotal Vivacity-MG3 trial in which IMAAVY (nipocalimab-aahu) demonstrated superior disease control throughout 24 weeks when compared to placebo plus standard of care.
Improving Relationships and Diversifying the Site Selection Process
April 17th 2025In this episode of the Applied Clinical Trials Podcast, Liz Beatty, co-founder and chief strategy officer, Inato, discusses a number of topics around site engagement including community-based sites, the role of technology in improving site/sponsor relationships, how increased operational costs are impacting the industry, and more.
Behind the Buzz: Why Clinical Research Leaders Flock to SCOPE Summit
February 7th 2025In this episode, we meet with Micah Lieberman, Executive Conference Director for SCOPE Summit (Summit for Clinical Ops Executives) at Cambridge Innovation Institute. We will dive deep into the critical role of collaboration within the clinical research ecosystem. How do we bring together diverse stakeholders—sponsors, CROs, clinical trial tech innovators, suppliers, patients, sites, advocacy organizations, investors, and non-profits—to share best practices in trial design, program planning, innovation, and clinical operations? We’ll explore why it’s vital for thought leaders to step beyond their own organizations and learn from others, exchanging ideas that drive advancements in clinical research. Additionally, we’ll discuss the pivotal role of scientific conferences like SCOPE Summit in fostering these essential connections and collaborations, helping shape the future of clinical trials. Join us as we uncover how collective wisdom and cross-industry partnerships are transforming the landscape of clinical research.
