What is BaseCase?
Developing interactive and easy-to-use stakeholder engagement content market access, medical affairs, and sales field teams…
CertaraJuly 20, 2021
Strategic Planning and technology to support a rolling BLA submission under tight timelines
A Tier 3 Sponsor called upon Certara to support its rolling BLA submission, the second…
CertaraJuly 19, 2021
Open-Source Modeling Tools: Fueling the Fire vs. Extinguishing the Debate
The paper “Opening a Debate on Open-Source Modelling Tools: Pouring Fuel on Fire vs. Extinguishing…
CertaraJuly 15, 2021
Determining Exposures when Transitioning Between Combination Treatments in Cystic Fibrosis: Trikafta
Determining Exposures when Transitioning Between Combination Treatments in Cystic Fibrosis: Trikafta
Many cystic fibrosis (CF) patients take several medications at one time to manage symptoms and…
CertaraJuly 14, 2021
Voxelotor for Treating Sickle Cell Disease: Leveraging Dose Prediction Model for DDI Prediction Without Any Clinical Studies
In November 2019, the US FDA granted accelerated approval for Oxbryta™ (voxelotor) tablets for the…
CertaraJuly 14, 2021
Key Considerations to Ensure Maximal Probability of Antibody Drug Conjugate Development Success
Antibody drug conjugates (ADC) are a unique way to obliterate tumor cells and represent an…
CertaraJuly 8, 2021
Meet a Certara regulatory operations specialist
Meet Rachel Bombara, Sr. Regulatory Operations Specialist at Certara. In this brief video Rachel shares…
CertaraJuly 2, 2021
Maximizing Oligonucleotide Therapeutic Development: Pre-clinical and Translational Considerations
This is the second of three blog posts discussing best practices for developing oligonucleotide therapeutics.…
CertaraJune 25, 2021
Complex patient profile and narrative template needs
A global pharmaceutical company came to Certara to generate both patient profile (PPL) and narrative…
CertaraJune 24, 2021
Fundamentals of regulatory writing: the document development process
Regulatory writers lead the development of high-quality regulatory documents by working incollaboration with colleagues across…
CertaraJune 22, 2021
