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
Tag: Clinical Trials
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
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 were used to optimize a sponsor’s Phase 3 clinical trial study design to achieve efficacy and safety goals as well as regulatory approval.
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.
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. Speakers: Demetrius Carter, SVP … Continued
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.
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.
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.
Computer simulation provides an effective means for evaluating whether a clinical trial design is efficient and optimally informative with a high likelihood of success. Many variables affect the likelihood of success of a trial, and genetic variation in the population is being evaluated with increasing frequency for its impact on trial outcomes.