Track Investigator Reports
Applied Clinical Trials spoke to Roy Devine, Associate Vice President at Patni Life Sciences, a technology consulting and integration firm, about technology issues recently. One pressing issue that may become more important for sponsors in the coming months is in regard to the EU's Clinical Trials Directive. Specifically, sponsors may be concerned about the recent uptick in enforcing the requirement that sponsors know that their investigators are reading, understanding, and signing crucial safety documents or SUSARs (suspected unexpected serious adverse reaction reports).
"The EU reporting requirement has been around for a few years, but now it's being enforced," explained Devine. "Sponsors don't have a technical way to make sure that investigators have read the information on safety." So what he is seeing now is an increase in companies cited for underreporting.
Devine does not fault the sponsors at all. Basically, the situation is that some of the sponsors keep this information in an Excel spreadsheet, which doesn't have the level of "riguer" necessary for tracking. "Sponsors are good at sending information to the regulatory authorities and are comfortable with it," explained Devine. But in regard to the SUSARs and other safety reports for the regulatory authorities, sending out to the investigators is a bit of a hodge-podge. From faxing to Documentum to emailing, Devine described a blind distribution system that doesn't actually offer accountability.
"It is not a closed-loop system. There is nothing in the process that says you read and understood the document," said Devine. And that is what sponsors should be working toward now, a closed loop system that addresses these concerns. Devine said, "Some sponsors are doing it. And others aren't. But it is something that needs to be addressed."
Behind the Buzz: Why Clinical Research Leaders Flock to SCOPE Summit
February 7th 2025In this episode, we meet with Micah Lieberman, Executive Conference Director for SCOPE Summit (Summit for Clinical Ops Executives) at Cambridge Innovation Institute. We will dive deep into the critical role of collaboration within the clinical research ecosystem. How do we bring together diverse stakeholders—sponsors, CROs, clinical trial tech innovators, suppliers, patients, sites, advocacy organizations, investors, and non-profits—to share best practices in trial design, program planning, innovation, and clinical operations? We’ll explore why it’s vital for thought leaders to step beyond their own organizations and learn from others, exchanging ideas that drive advancements in clinical research. Additionally, we’ll discuss the pivotal role of scientific conferences like SCOPE Summit in fostering these essential connections and collaborations, helping shape the future of clinical trials. Join us as we uncover how collective wisdom and cross-industry partnerships are transforming the landscape of clinical research.
Reaching Diverse Patient Populations With Personalized Treatment Methods
January 20th 2025Daejin Abidoye, head of solid tumors, oncology development, AbbVie, discusses a number of topics around diversity in clinical research including industry’s greatest challenges in reaching diverse patient populations, personalized treatment methods, recruitment strategies, and more.
