Navigating the FDA Emergency Use Filing Process
In an effort to create safe, effective, and affordable ventilators to help combat the foreseeable shortages due to COVID-19, one
sponsors
Improving Patient Centricity and Research Access
A clinical research trial can only be as strong its participant population, but it’s challenging to find eligible patients.
For FDA Inspection Readiness, Accountability is Key
Dawn Wydner, former Food and Drug Administration (FDA) Consumer Safety Officer, LCDR, and current Managing Expert for Advarra’s Quality Center
Top 10 Educational Resources of 2021
The year 2021 brought many advancements in the clinical research industry. We’ve pushed for more diversity and inclusion in clinical
Q&A: FDA Updates: BIMO – What Sponsors Need to Know
Advarra experts Joan Versaggi and Leslie Paul answer questions from the first in the webinar series – FDA Updates: BIMO
The Key to Increasing Diversity in Decentralized Trials
Historically, decentralized clinical trials (DCTs) were heralded as the future of patient-centered research. But how can your organization “walk the
Unique Ethical Issues in Phase I Oncology Studies
Phase I oncology trials present distinct ethical challenges, such as participant vulnerability and the risk of therapeutic misconception, requiring careful oversight.
Returning to In-person Work: Sponsor Versus Site Viewpoints
As March 2020 completely disrupted any sense of normalcy, including in the workplace, many were forced to adapt rather quickly.
Maintaining Data & Reporting Integrity with Mobile Health
As the COVID-19 pandemic has forced a shift toward remote modalities, mobile health (mHealth) technologies have been on the rise.
Op-ed: Missing Elements of the Discussion on Decentralized Trials
The discussion on decentralized clinical trials (DCTs) has been brought to the forefront in the wake of the COVID-19 pandemic.
Does This Study Require IBC Review?
Gene therapy research is highly regulated due to associated risks, often leading to confusion among professionals new to its regulatory requirements.
Sites: The Key to Patient Centricity in Clinical Research
We’ve heard and used the term “patient centricity” for years now, and with good reason. It’s an important consideration in