Using Real Word Evidence to Enhance Drug Development Case Study Using Real Word Evidence to Enhance Drug Development Real-world evidence (RWE) has emerged as an increasingly important tool in the drug development process,1…CertaraApril 5, 2023
Leveraging Clinical Data from One Rare Disease to Support Drug Approval for Another Case Study Leveraging Clinical Data from One Rare Disease to Support Drug Approval for Another Atypical hemolytic uremic syndrome (aHUS) is an ultra-rare genetic disease that causes abnormal blood clot…CertaraJune 1, 2022
Choosing an eCTD Submissions Vendor: Your Complete Checklist Blog Choosing an eCTD Submissions Vendor: Your Complete Checklist September 3, 2025 Selecting the right electronic submission vendor for regulatory submissions to health authorities…CertaraJanuary 28, 2022
A Bird’s Eye View on Rare Diseases: Key Drug Development Considerations for Thyroid Eye Disease Blog A Bird’s Eye View on Rare Diseases: Key Drug Development Considerations for Thyroid Eye Disease New therapeutics discovery and development for ocular diseases have been traditionally associated with a low…CertaraDecember 15, 2021
Dose Optimization Using Population PK for an Orphan Drug Case Study Dose Optimization Using Population PK for an Orphan Drug RAPALIMUS® Tablets (sirolimus) is Nobelpharma’s orphan drug developed from an oral medication that is sold…CertaraNovember 17, 2021
Defining path-to-market strategy through a data-driven and scientific approach Case Study Defining path-to-market strategy through a data-driven and scientific approach How Certara supported a gene therapy manufacturer by using a selection of gateway and value…CertaraOctober 28, 2021
Using Real-world Evidence to Advance Market Access for New Therapeutics White Paper Using Real-world Evidence to Advance Market Access for New Therapeutics CertaraSeptember 29, 2021
The Scary Future of Rare Disease Management On-Demand Webinar The Scary Future of Rare Disease Management In a world of rising healthcare costs, the greatest nightmare for payers is reimbursing drug…CertaraSeptember 23, 2021