01.09.23 -- How To Educate Regulators On What Matters To Patients

Industry and academia alike are experiencing a greater urgency for awareness, education, understanding, and application of diversity, equity, and inclusion (DEI). This begs the question of whether people are willing to move from the comfort of “recommended” training to the potential discomfort and discord inherent in “required” training.

Explore why the Facebook ban on ads that target patients is an opportunity to push clinical research to accelerate more patient-centric advertising models that enable privacy.

Early feedback from users of the EMA’s new centralized clinical trials information system (CTIS) is broadly positive, according to a survey of 400 U.S. and European life sciences leaders. CTIS use isn’t mandatory until after the end of January 2023, but industry uptake has already been strong.

Discover why it is critical to embrace the right technologies in order for sites to improve performance and grow their chances for securing new studies.

Prevent trial delays by empowering your CRAs to monitor more sites per week, to focus on strategic activities, and to work with a wide range of sites. Florence’s SiteLink™ creates a digital link between CRAs and sites that enables remote monitoring and document sharing.

With the greater emphasis on patient centricity, patients are valued as an active participant in their own care. There is an increased emphasis on evaluating treatment benefit using patient-centric concepts and input from the patient community. Regulators now urge sponsors and researchers to systematically engage patients and caregivers to define the disease burden and unmet needs.

Industry experts discuss how a medical device company implemented ePRO to close gaps in data accuracy, reduce context switching for staff, and enhance patient convenience.