Nextrials Meets with CDER Healthcare IT Group
At the invitation of the FDA, Nextrials recently demonstrated to members how the integration capabilities of its Prism® clinical data and trial management platform could improve data collection and drug safety reporting.
At the invitation of the FDA, Nextrials recently demonstrated to members how the integration capabilities of its Prism® clinical data and trial management platform could improve data collection and drug safety reporting. Using its electronic health record (EHR) integration tool, E2E™, Nextrials staged a live demonstration for the Center for Drug Evaluation and Research (CDER) Healthcare IT Group and authors of the FDA's eSource Guidance.
This demonstration enabled attendees to examine how the integration of electronic data collection (EDC) in clinical trials with individual patient EHRs could not only provide benefits from a regulatory perspective, but also could boost patient care from the standpoint of healthcare providers. Nextrials also met with authors of the FDA eSource Guidance. The eSource Guidance provides recommendations for the use of electronic source data in FDA-regulated clinical investigations. The application of this guidance was discussed from the perspective of sponsors, patients, e-clinical software vendors and treating physicians.
Including Women of Childbearing Age in Clinical Research
March 26th 2024In recognition of International Women's Month, we're featuring this recent talk between Associate Editor Miranda Schmalfuhs and Marie Teil, Global Head of UCB’s Women of Childbearing Age Program. They speak about the specific challenges women with chronic illnesses face when accessing appropriate treatment and participating in clinical trials, UCB's Women of Childbearing Age Program and it’s most successful strategies, and much more.
Improving Engagement While Maintaining Data Integrity & Validity
March 19th 2024In recognition of Women's Health Month, we're featuring this recent talk between Associate Editor Miranda Schmalfuhs and uMotif's Chief Product Officer, Julia Lakeland, discuss new technologies improving patient engagement and reducing the emotional and logistical burdens of participation, ethical considerations that should be addressed when implementing those technologies, while ensuring patient privacy, and much more.
