A new benchmarking study that assesses vendor qualification assessment (VQA) practices is aimed at helping sponsors, CROs and sites streamline and reduce the cost of selecting vendors, a task that is increasing in complexity. Read More
This monthly feature presents a variety of questions from clinical trial professionals with answers from WCG Clinical’s expert staff. This issue features advice from Patience Stevens, vice chairperson at WCG Copernicus Group IRB, and Lindsay Abraham, regulatory lead for IRB chairs at WCG Western IRB (WIRB). Read More
COVID-19 has caused nearly half of all trial disruptions in the past five months, with oncology trials being hardest-hit, according to a new study out of Berlin. Read More
The number of women who participated in clinical trials that led to FDA drug approvals increased dramatically in the past year, rising from 56 percent of trial participants in 2018 to 72 percent in 2019, driven more by an increase in testing drugs specifically aimed at women than gender diversity. Read More
When it comes to deciding how to compensate principal investigators (PIs), sites have three factors to consider and getting them wrong carries a high cost, says one expert. Read More
When developing a plan to gather and analyze vendor performance metrics, the first question to ask is how wide to cast the net for collecting data. Read More
When a site undergoes an FDA inspection, just because its policies and procedures pass muster doesn’t mean the agency won’t ask for more proof of data reliability. Read More
Global trial recruitment rates have been on an upward swing over the past seven years, thanks to new techniques designed to make patient participation easier, but the benefits have not translated to trials’ ability to retain patients. Read More
Studies based on real-world evidence (RWE) don’t have to be a replacement for randomized clinical trials but rather an integral part of an overall trial strategy. Read More