临床试验软件如何帮助提高研究效率
临床试验在推动医学研究和改善患者治疗效果方面发挥着至关重要的作用。研究的有效性在很大程度上依赖于前沿技术来优化和加速研究的构建和提交流程。 在本博客中，我们将介绍一些革新研究人员设计、管理和分析试验方式的创新软件解决方案。Armed … Continued
Tag: 临床试验
New FDA Guidance on Penalties Relating to ClinicalTrials.gov
By Carrie Mitchell and Jason Buck Recently, the FDA issued a guidance concerning the penalties for noncompliance with ClinicalTrials.gov requirements. Sponsors conducting clinical trials should understand and follow the requirements for registering trials and reporting the results on ClinicalTrials.gov. The requirements have been in force since 2007 and were part of Section 801 of the … Continued
Virtual Bodies for Real Drugs: AI May Speed Up Clinical Trials and Save More Lives
For years, drug companies had only one way to find out if a new medicine or vaccine works: patient-based clinical trials. But a community of virtual patients is promising to modernize the drug testing process by predicting drugs’ effects. The resulting studies, called in silico trials, use artificial intelligence (AI)-based simulation technology to mimic human … Continued
Salvaging CNS Clinical Trials Halted Due to COVID‐19
The coronavirus disease 2019 (COVID‐19) pandemic has halted many ongoing central nervous system (CNS) clinical trials, especially in Alzheimer’s disease. These long‐duration trials involve many stakeholders, especially the patients and their family members, who have demonstrated their commitment to developing new therapeutic interventions for this devastating disease. We certainly do not want to lose all … Continued
Modeling and Simulation: Optimizing Phase 3 Study Design to obtain FDA Approval
Modeling and simulation were used to optimize a sponsor’s Phase 3 clinical trial study design to achieve efficacy and safety goals as well as regulatory approval.
10 Things You Should Consider When Planning a COVID-19 Clinical Drug Trial
This blog asks and answers 10 critical drug development questions whether you have a new molecular entity or are repurposing a drug already in clinical use.
新冠肺炎期间管理临床试验和监管提交策略的注意事项
COVID-19 has the potential to negatively impact critical activities such as patient recruitment, patient safety and ensuring data integrity. Thus, clinical developers should review their planned regulatory filing strategies to determine if modifications are required. Attend this webinar to learn mitigation strategies and best practices that you can begin implementing now. 演讲嘉宾：Demetrius Carter, SVP … Continued
Changing the Game in Oncology Drug Development and Patient Access
Maximize your understanding of your anti-cancer drug’s safety and efficacy profile to achieve regulatory and commercial success with Certara’s strategic and technology-enabled services across the entire drug development continuum – from pre-clinical first-in-human studies to regulatory submissions, health economics/outcomes research and market access value communication.
在新的 Trial Simulator 中模拟病毒动力学
Watch this webinar to learn how to use simulation to anticipate risks and preview the range of possible trial results before millions of R&D dollars are spent exposing subjects to experimental therapies.
Using Realistic Covariates with New Trial Simulator to Optimize Meropenem Dosing in Renally-impaired Children
Learn how to use trial simulation to anticipate risks and preview the range of expected results before millions in R&D dollars are spent, and subjects are exposed to experimental therapies.
