News By: Gary Cramer

Managers today want new employees to come in and hit the ground running, but you need to spend time up front with these individuals—whether they are research-naïve newbies or seasoned veterans—to get a return on your investment in them. That means defining a full research training and development program tailored to your site to ensure all employees are appropriately trained.

Historically, the clinical research industry has referred to a decentralized model as a DCT or hybrid trial. Now, the FDA is reframing it to simply be what it is—a clinical trial with decentralized elements, such as telehealth visits, electronic informed consent, and digital health technologies (i.e., wearable devices).

Advances in the cancer treatment space have renewed hope for breakthroughs with personalized cancer vaccines (often also called personalized immunotherapies). Despite the promise, experience shows that there are many challenges that innovators need to overcome from a development, regulatory, and chemistry, manufacturing, and controls perspective.

October is the time for the 2024 ACRP Membership Meeting, and there is so much to celebrate this year. During the virtual meeting earlier this month, presenters discussed how ACRP is advancing the people and practice of clinical research in a multitude of ways.

An interview with Andrew MacGarvey, who has been involved in the clinical research enterprise for more 25 years and is now CEO and Founder of Coronado Research, which recently launched in the United Kingdom as a consultancy-led, professional services organization operating in the clinical development arena.