Shree Kalluri, Founder and CEO, Forte Systems

Uptake of Technology Tools Gaining Traction for Boosting Clinical Trial Performance

Adoption of technology in a wide swath of clinical trial operations is on the rise because systems are becoming more nimble and affordable, says Shree Kalluri, founder and CEO of Forte Research Systems, a clinical operations company that provides technology and services to help research sites, cancer centers, and academic institutions streamline clinical research operations […]

US Senate

Senate Moves to Speed Clinical Trial Pathways

There aren’t too many bipartisan things happening on Capitol Hill these days, but a new U.S. Senate bill designed to speed clinical trials appears to be one of them. As introduced earlier this month, the Enhanced Clinical Trial Design Act would mandate a public meeting between the National Institutes of Health (NIH) and the Food […]

Anne Zielinski, Vice President for Technology Alliances, Bioclinica

Sites Hope Technology Benefits are Poised to Turn Their Way

After a long wait, some clinical research enterprise experts are seeing a shift in how technology is used at the site level. In the past, technology was mostly used to record data and focused on sponsors, says Anne Zielinski, vice president for technology alliances at Bioclinica. “That was the situation for more than a decade” […]

Sloppy Quality Management Programs Spell Trouble Down the Line

“We’re always talking about quality, but it’s more than a buzzword,” says Wendy Troccio, a trial regulations and compliance expert based in Chicago. The difference today? More and more trial practitioners “realize you have to have a plan based on standards and federal regulations,” she explains. That said, any effective program must be tailored to […]

FDA Logo

FDA/NIH Final Protocol Template Could Boost Trial Efficiency

A year in the making, the U.S. Food and Drug Administration (FDA) and National Institutes of Health (NIH) just unveiled a final version of a template for investigators to use when organizing clinical trial protocols. Calling it a roadmap for conducting a trial, Center for Biologics Evaluation and Research Director Peter Marks, MD, noted that […]