FDA inspections can glide smoothly or run off the rails, depending on how thoroughly and thoughtfully sites and sponsors prepare for them. Before the agency shows up, consider 10 key factors to gauge your inspection readiness. Read More
The language in clinical trial agreements (CTA) must be very specific to avoid legal problems during the trial, but certain terms have the potential, if not handled correctly, to derail the negotiation process before the trial gets off the ground. Read More
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
At the intersection of risk-based quality management (RBQM) and performance metrics, sponsors are increasingly using centralized monitoring approaches to analyze data from sites that can predict risk and identify sites that may need additional support. 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
