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For one University of Minnesota Duluth researcher, bringing a study from idea to implementation felt like a monumental climb. Often, simply knowing where to begin and who to go to can be the biggest barrier to moving a great idea forward.

In this post, we will discuss maintaining your Investigational New Drug (IND) or Investigational Device Exemption (IDE) with the FDA after you receive permission to begin your study.

Venturing into research involving a medical device was unfamiliar territory, but the Clinical Research Support Center (CRSC) helped Dr. Stephanie Misono navigate the challenges. 

A refreshed design of the Biostats4You website makes it easier than ever for medical researchers and professionals to find statistical resources for strengthening their understanding of biostatistics. Explore biostats resource

Including community health workers—sometimes referred to as CHWs—in research is highly valuable and is of greatest importance when using community-based participatory research approaches.They are trusted community members, and serve as…

In this post, we outline what University of Minnesota sponsor-investigators need to submit in their initial Investigational Device Exemption (IDE) application to the Food and Drug Administration (FDA).

Use these seven essential practices for stronger, more resilient partnerships between academic researchers and community members.

Last month, Nicole Tosun, MS, CCRP, gave a presentation on a continuous process improvement approach at the national annual Society of Clinical Research Associates (SOCRA) conference. The annual SOCRA conference, held in Chicago this year…

In this post, we outline what University of Minnesota sponsor-investigators need to submit in their initial Investigational New Drug (IND) application to the FDA.

Planning research in partnership with communities opens the door to meaningful insights and real-world impact — but it also requires careful thought, collaboration, and cultural understanding from the start. That’s where CHAT Sessions…