CRO Update: Where are Contract Research Organizations Headed?
2022年3月10日 · Contract research organizations (CROs) have undergone significant changes in recent years, and even more changes are on the horizon. Some of the new and established trends in CROs are the result of technological advances, while others have arisen in response to market pressures or the COVID-19 pandemic.
News - Applied Clinical Trials
An updated long-term analysis of the Phase III KATHERINE trial confirms that adjuvant treatment with Kadcyla (trastuzumab emtansine) significantly improves overall survival and long-term invasive disease–free survival compared to trastuzumab monotherapy in patients with HER2-positive early breast cancer with residual invasive disease.
Clinical Monitoring: Answers to Questions about Good Clinical …
2003年7月1日 · It its core, good clinical practice (GCP) is a set of broad regulatory requirements, standards, and recommendations that apply to thousands of highly specific tasks, processes, and roles in the conduct of clinical research.
Applied Clinical Trials
Latest solutions, case studies, interviews, practical articles for clinical trials operations, data management, technology, investigative sites and services.
The Strategic Emergence of Site Networks in Clinical Research
2024年10月14日 · 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 centralized operations may be better suited for large-scale, multi-site trials, while a smaller, independent site may be ideal for niche studies requiring specialized expertise.
Journals - Applied Clinical Trials
Latest solutions, case studies, interviews, practical articles for clinical trials operations, data management, technology, investigative sites and services.
CTMS: What You Should Know - Applied Clinical Trials
2016年3月18日 · ** : Bespoke Solutions based on extending CRM solutions OR Platform (PaaS) Summary. The myriad scientific, regulatory, and marketplace changes taking place in clinical trial management are creating a pressing need for innovative solutions that can span and integrate multiple, geographically dispersed trial partners and sites.
Spotlight on Open-Label Extension Studies - Applied Clinical Trials
2006年7月1日 · Open-label extension (OLE) studies are common, but they do not receive as much attention as traditional Phase I through Phase IV studies. Enrollment into an OLE study typically follows enrollment into a randomized, blinded, well-controlled main study. Participants are usually informed at the time they are recruited into the main study that they may elect to enroll in an OLE study after ...
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 survival and long-term invasive disease–free survival compared to trastuzumab monotherapy in patients with HER2-positive early breast cancer with residual invasive disease.
Estimand Framework: What it is and Why You Need it
2020年2月27日 · 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 for secondary trial objectives that support regulatory approval …