FDA inspections have been heavily focused on sponsor, CRO and site outsourcing activities since the Bioresearch Monitoring (BIMO) Program revised its manual for inspection processes in September 2021. Read More

With clinical research professionals exiting the industry in droves, it’s high time for research institutions to step back and assess themselves internally, evaluating how their own paradigms, cultures and priorities affect employees. Read More

The FDA has signaled its support for the use of real-world data (RWD) — information gleaned from health records, patient registries and other sources — through pilot programs and guidances but has yet to set standards for the quality of that data, leaving sponsors, investigators and sites to find their own way to evaluate its relevance and reliability. Read More

Resumes and traditional interviews don’t always provide a complete and accurate picture of job candidates, as St. Lawrence Health System learned the hard way. Seeking a better view of potential hires, they’ve created a process that appraises soft skills and traits that can’t be adequately assessed through resumes and generic interview questions. Read More

Close sponsor contact, rapidly moving targets and timelines, unique facility and staff needs — these are only some of the factors that can make phase 1 trials more challenging for sites than the other phases, say several oncology research experts who offer advice for sites considering signing up for early-stage research. Read More

Social media platforms are giving traditional television, print and radio advertising a run for their money, according to one marketing expert who says lower cost is not the only benefit of publicizing clinical trials on Facebook, Instagram, Twitter and Pinterest. Read More

Bayer’s efforts to make the charitable donation of unused trial kits and supplies an industrywide practice earned it the top spot at the inaugural WCG Innovation Challenge held at the MAGI Clinical Research Conference West in Las Vegas, Nev., last week. Read More

Sites, sponsors, CROs and investigators that start preparing for an FDA inspection when they receive a notice from the agency may already be too late to ensure success. Instead, experts advocate for maintaining a constant state of “inspection readiness” to avoid last-minute problems and surprises. Read More

Although people with disabilities make up the largest minority group in the U.S., they have been largely left out of discussions of diversity, equity and inclusion (DE&I) in clinical trials, making them one of the most underrepresented populations in research, say two researchers who recommend sites and sponsors pay more attention to their unique needs. Read More