Katrina Quidley

Site Quality Devils are in the Daily (and Weekly and Monthly) Details

Dogged dedication to reviewing documents and keeping training on the cutting edge at study sites are keys to an effective quality assurance (QA) program, says Katrina Quidley, regulatory manager with IACT Health in Columbus, Ga. “We review every interim monitoring visit letter as it comes in,” Quidley says of her efficient shop. Letters are sorted […]

Are Clinical Trial Sites Leaving Billable Items on the Table?

A growing number of billable items are not automatically included in contract agreements between study sites and sponsors, says Bonnie Segal, vice president of Segal Institute for Clinical Research. The upshot? Sites often leave money for a number of billable activities on the negotiating table, she says. “When it comes to negotiating a contract on […]

Clinical Trial Site QA Management Programs Prevent Operational Pain Down the Road

It’s easy for overwhelmed sites to get off-track and overlook critical gaps in their quality training programs, says David Morin, director of research at The Holston Medical Group in Kingsport, Tenn. “We’re all so busy and resources are so tight,” he acknowledges. That said, high-quality, proactive training is key to better site management and bolstering […]

Michael Causey, ACRP Editor-In-Chief

CTTI Project Reveals Serious Flaws in Trial Recruitment Protocols

Failure to address clinical trial recruitment issues at the outset continues to plague sites, according to the findings of a new task force. Result? Nearly 40% of clinical trials fail to meet recruitment goals. It's time to change that, say members of the Clinical Trials Transformation Initiative (CTTI) Recruitment Project team. CTTI is a public-private […]

Culture-Driven Patient Recruitment and Retention

Culture, not language, is the greatest impediment to enrolling participants in clinical trials, and moreso in trials that are conducted partially or completely outside the sponsor’s home country. While language obstacles can be overcome with accurate and timely translation, culture’s impact is often overlooked or disregarded when it comes to generating voluntary participation from healthy […]