Using MBMA to run virtual “head-to-head trials” Case Study Using MBMA to run virtual “head-to-head trials” Osteoporosis is common in post-menopausal women. The long-term sequelae of osteoporosis include bone fractures, particularly…CertaraApril 21, 2023
Using Real-World Evidence to Derive an External Control Arm for a Rare Disease Drug Trial Case Study Using Real-World Evidence to Derive an External Control Arm for a Rare Disease Drug Trial Our client was developing a new anti-viral drug for a rare, life-threatening viral infection that…CertaraApril 17, 2023
Using Real World Evidence to Inform Treatment Guidelines Case Study Using Real World Evidence to Inform Treatment Guidelines Real-World Evidence (RWE) has become increasingly valuable in informing the development of treatment guidelines for…CertaraApril 5, 2023
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
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