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…

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…

Bringing new drugs and therapeutics to market is an expensive and time-consuming process. With so many policies and procedures to track and maintain, many biopharmas use electronic quality management systems (or eQMS) to centrally manage and monitor compliance.  When…

Mental illnesses are some of the most common medical conditions, affecting more than 57 million Americans. To put those numbers into perspective, the U.S. Centers for Disease Control and Prevention (CDC) notes: 1 in 5 Americans will experience a…

Vendor oversight is an important element, and a regulatory requirement, of all clinical trials just as proper communication is essential to any healthy working relationship. Many sponsors outsource some or all of the clinical trial responsibilities to a CRO,…

Workforce turnover has always been a challenge for Clinical Research Organizations (CROs), but the problem has accelerated during the last decade. If you’ve ever taken an Uber, stayed at an AirBnB or hired a TaskRabbit, you are participating in…

Workforce turnover has always been a challenge for Clinical Research Organizations (CROs), but the problem has accelerated during the last decade.  A recent study, published by BDO, emphasizes this issue, noting that “turnover in CROs has hovered around 25%…

Small biotechs and pharma companies have gained an increased percentage of the clinical research market over the last decade. While some experts may consider this growth a flash in the pan, a recent study conducted by McKinsey indicates otherwise;…

The success of a clinical trial relies on the integrity of the sponsors, vendors and other key decision-makers. While it would be nice to assume that all players uphold moral standards- particularly in an industry where the wellbeing of…