Key Considerations to Ensure Maximal Probability of Antibody Drug Conjugate Development Success Blog Post
Antibody drug conjugates (ADC) are a unique way to obliterate tumor cells and represent an underutilized immunotherapeutics option in oncology, whether as monotherapy or in combinations. The first FDA approval…
Incorporating the patient voice into clinical trial summaries Page
Certara offers Plain Language Documents to meet EMA/UK regulations with customizable templates, infographics, and accessible designs for clinical trial communication.
Maximizing Oligonucleotide Therapeutic Development: Pre-clinical and Translational Considerations Blog Post
This is the second of three blog posts discussing best practices for developing oligonucleotide therapeutics. The first blog in the series explained how these therapies work. Characterizing the pharmacokinetics (PK)…
Complex patient profile and narrative template needs Blog Post
A global pharmaceutical company came to Certara to generate both patient profile (PPL) and narrative templates for one of its most complex studies. Historically, the Sponsor’s statistical programming team had...
PK/PD Data Programming & Support Page
Bridge the gap between your analysis plans and modeling requirements.
Top 10 Benefits to Integrating the Simcyp PBPK Simulator into your Drug Development Program Blog Post
Per US FDA’s recent paper on the topic, Physiologically based Pharmacokinetic (PBPK) modeling & simulation impact on drug approval has grown significantly over the past years, with about 45% percentage…
Preparing for High Stakes Meetings; How to Best Convey a New Drug’s Value to Payers Blog Post
This blog post includes key takeaways from the opening session of Certara’s first Strategic Evidence and Value Communications Symposium. This session featured the following four speakers: Shawn W. Bates is…
Watershed Moment for the Future of Cell Therapy Development – FDA Advisory Committee Meeting Blog Post
Every FDA Advisory Committee meeting is unique, and the Cellular, Tissue, and Gene Therapies Advisory Committee meeting that took place on April 15, 2021 was not any different. The agenda…
