Top 10 Educational Resources of 2020

It’s safe to say 2020 has been more unpredictable than anyone could imagine. Through these unprecedented times, we have worked to provide the research community with resources to navigate the new normal. As the end of the year draws near, let’s take a look back at popular blog posts and webinars garnering the most interest from research community members like you.

Top Blog Posts

Developing a Clinical Trial Budget Following Medicare’s Clinical Trial Policy and Device Regulations

There are many challenges involved in developing and negotiating a clinical trial budget that applies Medicare’s rules and regulations for device and drug clinical trials. This blog discusses such challenges and suggests strategies to assist with the process.

Beginner’s Guide to Investigator-Initiated Trials

While many clinical trials are initiated by life sciences companies, some also originate at an individual research site. An investigator-initiated trial (IIT) is launched by an investigator with an idea for a study they’d like to conduct. This article covers a basic overview of IITs and how they fit into the clinical research landscape.

IRB Review of Coronavirus and Other Emerging Infectious Disease Research: Issues to Consider

As COVID-19 cases began to rise in the U.S. earlier this year, Advarra IRB experts were quick to provide information on unique issues that research involving emerging infectious diseases like coronavirus can raise for IRB review. In this article, we underline multiple points for an IRB’s consideration when reviewing infectious disease research.

12 Items Auditors Look for When Reviewing an Investigator Site File

Maintaining complete and compliant documentation while managing the complex processes and interactions of a clinical trial can be complicated. In this blog, we discuss key details to consider as you prepare an investigator site file (ISF) for an audit.

Key Biosafety Considerations for Coronavirus Research

The outbreak of COVID-19 led to a surge of interest in coronavirus research, as well as concern about the risks associated with coronaviruses. This blog introduces coronaviruses, covers strategies the clinical industry uses to combat the outbreak, and opportunities, risks, and risk mitigation strategies for coronavirus research.

Top Webinars

Study Startup Success for the New Generation of Genetically Engineered Vaccines

The global COVID-19 pandemic brought vaccine research to the forefront, and a surge of research involving genetically engineered vaccines is currently taking place. However, studies involving investigational products containing engineered genetic materials also pose unique startup challenges. This webinar explores the latest trends in genetically modified vaccine and immunotherapies, outlines obstacles to study startup, and discusses strategies to move forward.

Research Staffing Strategies During Challenging Times

Many institutions have faced hiring freezes, furloughs, and changes in workflows due to the COVID-19 pandemic. Understanding the state of your clinical research staffing now and in the future are key components in changing your approach to staffing. Our webinar uncovers current research staffing challenges and provides institutions with an understanding of how to work through staffing reprioritizations and resourcing strategies.

Racial Diversity in Clinical Trials: Building Trust in Participant Engagement

While racial and ethnic diversity in clinical trial participation has long been an issue, COVID-19 vaccine trials have brought this issue to national attention. This panel discussion explores ways we can unlock the inherent trust between patients and community healthcare providers, encouraging diverse representation in clinical trials.

The Must-Haves of FDA and Common Rule Reporting Requirements

The Food and Drug Administration (FDA) regulations governing Investigational New Drug (IND) applications contain specific reporting requirements. Similarly, the Office of Human Research Protections (OHRP) regulations (also known as the Common Rule) also contain reporting requirements. While these two agencies’ policies sometimes differ, it’s critical for researchers to understand what must be reported to whom. This webinar discusses the basics of FDA and Common Rule reporting.

Accelerating the Recovery – IRB Review of Virtual Trial Technology

This year more than ever, technology played a hand in research as trials adapted virtual components to keep research moving forward. This webinar focuses on the current regulatory landscape governing mHealth and virtual trial application. Additionally, our presenter will uncover practical tips for IRBs to approach review of research involving virtual modalities.

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