Product Using Direct Data Entry Receives FDA Marketing Clearance
According to Target Health, this is the first product to be approved using for in its pivotal trial, direct data entry of patient data at the time of the clinic visit into an EDC system, with no need for paper records.
The FDA has cleared for marketing a medical cooling device from Lund, Sweden-based Dignitana. Digitana engaged Target Health as its CRO, using its web-based eSource-enable EDC system to collect direct data entry from patients. According to Target Health, this is the first product to be approved using in its pivotal trial, direct data entry of patient data at the time of the clinic visit into an EDC system, with no need for paper records.
Target Health and three major medical centers were inspected with no FDA findings related to Target Health’s approach to the paperless clinical trial. Digitana originally submitted for approval in March 2015.
Target Health is also reporting that an NDA with seven studies using the same paperless approach was submitted November 25 to the FDA, with other international submissions planned. Additionally, two pivotal trials in neurology are underway, as well as a study integrating EDC with the electronic medical record, which will begin in Q2 2016.
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.
