Who Monitors the Monitors? CRA Evaluations Essential to Better Trials and Relationships

In the best of all possible worlds, clinical trial teams at study sites get along professionally and productively with each and every clinical research associate (CRA) who visits in person or remotely to monitor the progress and compliance of studies on behalf of their sponsors. In the real world, however, the relationship may be more of a “can’t live with them, can’t live without them” scenario as far as the site team members’ feelings about certain CRAs are concerned.

Never Fear, Assertiveness is an Indispensable Soft Skill for Clinical Researchers

It’s a sentiment you may have heard already at more than one gathering of research professionals who work in or with clinical trial units based (even buried) within larger academic medical centers, hospital systems, networked medical practices, and the like: The duties of trial team members, other site staff, and their vendors are performed so “behind the scenes” compared to the rest of the institutions’ activities, it can be a struggle to get their priorities and contributions noticed properly by leadership.

Is ChatGPT Listening in On Your Next Informed Consent?

Various applications of AI are openly and not-so-openly filtering into the mainstream operations of clinical research sponsors and study sites, as in so many other professional settings. When it comes to the importance of the informed consent process and the forms used to explain the purpose, risk/benefit calculation, and scope of a clinical trial to participating patients, industry leaders urge caution from trial team members who may be hoping for ChatGPT to ease ICF-related burdens on their list of chores.
Sheila Mahoney-Jewels

HR in Action: The Traditional Corporate Ladder Might be Bad Medicine for the Drug Development Workforce

Years of voracious M&A activity industry wide have inevitably taken a toll on any sense of stability among many in the drug development talent pool. Long-term job security, once the hallmark of the pharmaceutical industry, is no more. Many workers, especially highly skilled experts, want to practice their craft far more than they want the supposed trappings of management.

Clinical Trials Could Yield Better Data with Fewer Patients Thanks to New Tool

The Rosetta stone became an invaluable tool for deciphering the previously untranslatable hieroglyphic style of Ancient Egyptian script because the other languages used on the stone were already known to linguists. Today, clinical researchers can take advantage of a new tool offering something akin to the Rosetta stone’s breakthrough gift—a way to take feedback from clinical trial participants that is often collected but left unused and translate it into actionable data.