Certara Launches Its Simcyp In Vitro Data Analysis Toolkit
This new standalone solution is designed to meet the needs of early-stage drug discovery and development researchers.
Certara®, the global biosimulation technology-enabled drug development company, announced the launch of its Simcyp In Vitro (Data) Analysis (SIVA) Toolkit, version 1.0. The SIVA Toolkit is designed to enable the analysis of complex in vitro studies, including those with whole cells, tissue samples and solid dosage forms. It combines model-based data analysis approaches to assess the metabolism, transport or dissolution/solubility of drugs with optimization algorithms in a statistical environment. This approach ensures that users do not need to have extensive modeling or statistical experience to use the toolkit.
Unifying Industry to Better Understand GCP Guidance
May 7th 2025In this episode of the Applied Clinical Trials Podcast, David Nickerson, head of clinical quality management at EMD Serono; and Arlene Lee, director of product management, data quality & risk management solutions at Medidata, discuss the newest ICH E6(R3) GCP guidelines as well as how TransCelerate and ACRO have partnered to help stakeholders better acclimate to these guidelines.
First Patient Dosed in Phase III Trial of Enhertu as First-Line Treatment for Endometrial Cancer
June 10th 2025In combination with rilvegostomig or Keytruda, Enhertu will be evaluated versus chemotherapy in the DESTINY-Endometrial01 study for the treatment of patients with HER2-expressing, mismatch repair proficient primary advanced or recurrent endometrial cancer.
