The Strategic Emergence of Site Networks in Clinical Research
Oct 14, 2024 · These attributes can help sponsors assess the potential of a site or network to meet the specific needs of their trials. For example, a site with a robust infrastructure and …
Talzenna Plus Xtandi Shows Significant Overall Survival …
Oct 10, 2024 · The combination of Talzenna (talazoparib; Pfizer) plus Xtandi (enzalutamide; Astellas and Pfizer) produced a statistically significant improvement in overall survival (OS) in …
FDA Finalizes Decentralized Clinical Trial Guidance
Nov 25, 2024 · The FDA's guidance is part of a broader effort to modernize clinical trials, improve efficiency, reduce participant burden, and expand access, particularly for underrepresented …
Regulatory CMC: Enhancing Biologics Development
Sep 11, 2024 · An experienced regulatory CMC team can provide expertise and support to quickly obtain the relevant GMO approvals in the different countries within the trial footprint without …
Phase III Trials Show Long-Term Efficacy of Cobenfy Treating …
Nov 1, 2024 · Data from a pair of Phase III trials presented at the 2024 Psych Congress demonstrate that Cobenfy (xanomeline and trospium chloride) maintained long-term efficacy in …
The Evolution of CRO and Sponsor Relationships - Applied Clinical …
Nov 16, 2023 · The landscape for clinical trials is ever evolving. 1 Adaptive trial designs, decentralized, and hybrid trials are becoming more prevalent, particularly in light of the COVID …
Applied Clinical Trials Online
January 16th 2025. An updated long-term analysis of the Phase III KATHERINE trial confirms that adjuvant treatment with Kadcyla (trastuzumab emtansine) significantly improves overall …
Building Relationships in Clinical Research
Oct 29, 2024 · In this video interview, Jimmy Bechtel, vice president, site engagement, SCRS, discusses the importance of communication between CROs, sponsors, and sites.
Applied Clinical Trials
Latest solutions, case studies, interviews, practical articles for clinical trials operations, data management, technology, investigative sites and services.
Estimand Framework: What it is and Why You Need it
Feb 27, 2020 · According to section A.6 of the ICH guidance 1, the clinical trial protocol should very clearly specify a primary estimand that addresses the primary study objective.Estimands …