The industry has been abuzz about risk-based monitoring (RBM) for much of the last decade, with the FDA indicating that it would like to see more sponsors give it a try. Read More

The research is clear: certified principal investigators (CPIs) and clinical research coordinators (CRCs) do better work compared with their peers who hold no certification. Much better work, in fact. Read More

Due to the vast influx of technology and the advent of Risk-Based Monitoring, the clinical research landscape is now evolving fast, and along with it, so are jobs in the field. Read More

eConsent has developed a reputation for being the next big technological innovation in clinical trials, and adoption efforts are accelerating. Read More

The media buzz last week on reported layoffs at IBM Watson Health ranged from calling it a “bloodbath” to something more surgical. Eventually, IBM Watson Health confirmed the layoffs at some of its acquired businesses, but wouldn’t say how many, and said it was continuing to hire in other new areas. Read More

Despite endless talk over the last decade of ways to make clinical trials shorter and simpler, trials have only gotten longer and more complicated. Read More

The Clinical Trials Transformation Initiative (CTTI)—the first consortium to pull widespread stakeholders together, including the FDA, to hash through and try to fix large-scale problems that have plagued the clinical research space—has turned 10. What has it accomplished? Read More

Orphan drug development takes 15.1 years to go from first patent filing to product launch, 18 percent longer than the average time required for all new drugs, according to the Tufts Center for the Study of Drug Development. And development time for drugs to treat ultra-orphan diseases—which affect only a few hundred patients in the U.S.—is even longer: 17.2 years. Read More

Clinical research is poised on the verge of a huge transformation driven by three factors: the patient engagement movement, rich data and analytics and the learning health system model. Read More

Do you understand everything you need to about the clinical trial agreement contracts you sign? Read More