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.
Applied Clinical Trials Online
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.
CTMS: What You Should Know - Applied Clinical Trials
Mar 18, 2016 · ** : 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.
Applied Clinical Trials
Nov 1, 2024 · 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 for secondary trial objectives that support regulatory approval …
WCG Announces the Formation of WCG IRB and Launch of WCG …
Oct 12, 2020 · WCG has announced the unification of its five IRBs—Western IRB (WIRB), Copernicus Group IRB (CGIRB), Midlands IRB (MLIRB), New England IRB (NEIRB), and Aspire IRB—into the single WCG IRB brand.
Key Cost Drivers in Clinical Research: Guide to Successful Budgeting
Oct 12, 2020 · Proper study budget is vital for a successful trial for both parties, contract research organizations (CRO) and pharma companies. Therefore, it is essential to take the time and prepare your financial plan by thoroughly thinking of all expenses.
The CRA of the Future: From ‘Road Warrior’ to Site ‘Owner’
Feb 13, 2024 · The role of the clinical research associate (CRA) is fundamentally important to the success of clinical trials. However, this role is undergoing significant transformation due to the changing dynamics within the clinical research industry.
CRO Update: Where are Contract Research Organizations Headed?
Mar 10, 2022 · 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.
Malaysia’s Clinical Research Ecosystem - Applied Clinical Trials
Jan 26, 2017 · The various initiatives taken so far by CRM to improve the clinical research ecosystem include recruiting, training and developing medical officers into future investigators; investing in various clinical research sites by equipping them with the necessary infrastructure to conduct clinical trials; shortening the clinical trial agreement (CTA) review and approval timeline from 14 working days ...