A number of early warning signs can indicate a site may be headed for trouble, both operationally and financially. Weak research strategies, misaligned incentives and poor business development functions can lead to low enrollment, budget overages and, ultimately, failed trials. Read More
Implementing an electronic regulatory (eReg) system can seem daunting to sites when it comes to the costs and time involved, but those that commit to it can reap multiple benefits, including faster study startup, increased efficiency and decreased long-term costs. Read More
In a congressionally mandated report on diversity in clinical trials, the National Academies of Sciences, Engineering and Medicine (NASEM) recommends the FDA require drug sponsors to file an in-depth recruitment strategy, either before or with their investigational new drug (IND) or investigational device exemption (IDE) applications, that details how they intend to make their trial population reflective of the disease or condition’s demographics. Read More
The FDA’s novel drug approvals continued to be supported by fewer, less rigorous and more flexible pivotal trials as well as surrogate endpoints in 2020, a new analysis has found. Read More
WCG has appointed healthcare industry veteran Sam Srivastava to take the helm as its new chief executive officer, overseeing all global operations. Read More
Cytel has been granted the Society for Clinical Trials’ (SCT) 2021 Trial of the Year Award for TOGETHER, an adaptive platform trial designed to expedite evaluation of nearly a dozen cost-effective COVID-19 therapies for low- and middle-income countries. Read More
