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How Clinical Trial Software Helps Make Studies More Efficient

Clinical trials play a crucial role in advancing medical research and improving patient outcomes. The effectiveness of studies relies heavily on cutting-edge technology to optimize and accelerate the study build and submission processes.   In this blog, we look at some of the innovative software solutions revolutionizing the way researchers design, manage, and analyze trials. Armed … Continued

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

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

Considerations for Management of Clinical Trials and Regulatory Filing Strategy in Light of COVID-19

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. 講演者Demetrius Carter, SVP … Continued

腫瘍薬開発と患者アクセスの枠組みを変革する

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.

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