Beginner’s Guide to Investigator-Initiated Trials
While many clinical trials are initiated by industry sponsors, such as pharmaceutical companies or contract research organizations (CROs), other trials
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Q&A – The Must-Haves of FDA and Common Rule Reporting Requirements
In a recent webinar, Advarra regulatory experts discussed the must-haves of FDA and Common Rule reporting requirements. They reviewed the basics of what must be reported to whom—and when—for sponsors and investigators involved in IND studies, as well as requirements for identifying, reviewing, and reporting unanticipated problems and noncompliance to IRBs and Common Rule departments or agencies. Due to time constraints we weren’t able to answer all audience questions during the Q&A period, so our experts have answered some of the most popular questions in this blog.
Getting “Engaged” in the Time of COVID
When using remote sites to perform clinical trial procedures, there are certain issues researchers must keep in mind, including whether those remote sites are considered to be engaged in research.
Q&A – Site and Patient Engagement
CEO Gadi Saarony and Deb Tatton, Parexel Senior Vice President of Global Clinical Operations, consider ways to improve site and patient engagement in this Fireside Chat Q&A blog part 2.
Q&A – The Evolving Role of Technology
In this Fireside Chat Q&A blog , CEO Gadi Saarony and Deb Tatton, Parexel Senior Vice President of Global Clinical Operations, share perspectives on technology’s evolving role in clinical research.
Introducing Fireside Chats: Conversations On Burning Research Topics
Advarra is excited to introduce Fireside Chats, a series of virtual conversations discussing current issues in clinical trials. Each Fireside Chat brings together perspectives from across the research community, enabling real-time discussion of contemporary challenges and potential solutions to help make research altogether better.
Clinical Trials Day: Thanking the Unsung Heroes
On Clinical Trials Day, now more than ever, it’s important to recognize and thank those unsung heroes at the focal point of research: research sites and institutions.
Empowering Employees Starts with Building a Strong Culture
Now more than ever, people are seeking out employment at organizations that offer more than just standard benefits. They are
How Research Informs the COVID-19 Response
Research doesn’t just inform medical treatment; it informs public health and public policy, and it helps explain human behaviors.
Most Popular Blogs of 2019
As we near the end of 2019, let’s take a look back at the blogs that generated the most interest this year from readers like you.
Meeting the Challenges of Investigator-Initiated Trials
Stem cell clinics with unproven treatments are on the rise in the US. Learn how the FDA is working to bring new stem cell therapies under federal oversight.
What’s the Difference Between Right to Try and Expanded Access?
The right to try movement and recent passage of the federal right to try law have renewed public interest in