It’s hard to believe, but 2023 is soon coming to a close. With the new year right around the corner, now is the perfect time to start thinking about and planning for your GxP vendor audits. Dealing with audits…
A fully functioning pharmacovigilance program is essential in any clinical study for a drug, biologic or medical device. If you don’t take the time to monitor, assess, and manage adverse reactions, you risk potentially devastating economic consequences or worse; endangering…
Recruiting patients for clinical trials is an expensive and time-consuming process, taking about 18 months on average. It’s no surprise then that many biopharmas and medical device manufacturers are taking steps to speed things up and make patient recruitment…
Clinical trial fraud is not an uncommon problem. Though it is difficult to comprehend, it’s something that should not be ignored. Despite the problem, there is some hope. According to industry insiders, regulatory scrutiny is starting to ramp up….
Designing and carrying out clinical trials has remained relatively unchanged over the last 10-20 years; most biopharmas outsource their studies to a single contract research organization (CRO). The CRO then manages most aspects of the clinical trial, including the…
Artificial intelligence (AI) technologies, like ChatGPT and Google Bard, are taking the world by storm. While most news coverage to date has focused on the potentially negative effects of these tools, it’s not all doom and gloom. When used…
Clinical trial safeguards have significantly improved over the last 50 years. The National Research Act, signed into law in 1974, established Institutional Review Boards (IRBs) to protect patients and increase public trust. In 1991, The Common Rule was adopted,…
Clinical research plays an essential role in identifying and developing new drugs and therapeutics. Yet safety is such a major concern that most Americans say they wouldn’t feel comfortable enrolling. Consider that a recent survey conducted by researchers at…
A healthy working relationship between a sponsor and their clinical research organization (CRO) is integral to the success of any clinical trial. When both parties trust and respect one another and communicate clearly, it’s much easier to stay on…
At the beginning of May, the FDA released updated draft guidance on designing and implementing decentralized clinical trials (DCTs). The draft document fulfills Section 3606(a) of the Food and Drug Omnibus Reform Act, requiring the FDA to issue guidance…
