It’s not uncommon for sites initiating a new study to be unsure about where they should start on the standard study documents, such as coverage analysis, internal budget, sponsor budget, clinical trial agreement, payment terms and informed consent form. Read More
As on-site monitoring continues to dwindle, collecting quality metrics is no longer the sole province of the sponsor. Sites are stepping up to focus on risk management and quality that matters. Read More
Trial startups are taking longer and longer, with approaches used so far failing to consistently speed up the pace despite some success in addressing growing trial complexity. Read More
Trial investigators are consistently grappling with what they should submit to their IRBs, with changes in research (CIRs) topping the list of areas they’re unclear on. But a simple approach can be adopted on that front: always send them to the IRB. Read More
A global study conducted by Tufts’ Center for the Study of Drug Development (CSDD) and the Bill & Melinda Gates Foundation found that while trial researchers view themselves as effective at working from home and wish to continue doing so, the move to teleworking has also led to burnout. Read More
As the number of biotech trials continues to rise, sites should not underestimate the complexities such trials pose for site staff and sponsors, experts say. Read More
Staff at Cedars-Sinai Medical Center had their hands full implementing two new major technology systems over the past two years. Then the pandemic hit, adding a huge burden to already-strapped employees, who managed a record 141 trial agreements by the end of last year. Read More
The switch to virtual site training during the past year has not only saved time and travel, it’s allowed staff to have access to quick on-demand reference materials from their training they can refer to as they encounter real-world situations. Read More
Four years ago, nearly all digital tools used in clinical trials were ECG devices, but 2021 data show that they have shrunk to 63 percent of the total, edged out by wearable devices, connected sensors, digital biomarkers and other new technologies. Read More
While the clinical trial landscape has seen a historic rise in trial starts year over year and shown a significant recovery from the far-reaching impact of the COVID-19 pandemic, there’s been a troubling burnout rate among clinical investigators, a phenomenon that concerns sites and sponsors. Read More