IMARC Research is committed to being an industry thought leader and publishes whitepapers on a wide-range of clinical research topics. We welcome and encourage you to visit and download these documents for reference.
If you have any thoughts regarding one of our papers or ideas on a relevant topic for a whitepaper, please contact us.
Featured Whitepaper:
The Top 5 Trial Complications
Recent widespread recalls of investigational products have led to harsher scrutiny and stricter rules from the Food and Drug Administration (FDA). Steps take to prepare for trials in the past are no longer enough. This document highlights the top five key areas that can complicate medical device trials.
Previous Whitepapers:
Determining Risk Category and IDE Exemptions
The purpose of this whitepaper is to clear up confusion about the process for determining if an investigational device is Significant Risk (SR) or Non-Significant Risk (NSR) and if a NSR device study is exempt from certain IDE regulations.
IMARC's 2011 warning letter "report card" is in! After reviewing warning letters issued to investigators and sponsor-investigators in 2011 through the FDA's Bioresearch Monitoring Inspection Program, IMARC’s clinical monitoring team has assembled the following "TOP 10" list.
Proving Patient Protection
This white paper will examine a small sample of the requirements in clinical research, which at times, can be confusing, and will provide recommendations for how to think through situations to ensure that your documentation adequately proves that you protected subjects throughout the study.
Effective Monitoring for a Medical Device Trial
The art of effective monitoring requires more than just an individual or a title, more than just a comprehensive procedure or checklist – it requires a mindset on the part of everyone who touches that clinical trial.
Conducting a Well-Controlled Clinical Study When Clinical Data is Required The purpose of this whitepaper is to establish the current status of the 510(k) process with regard to clinical data requirements, and then to begin to define some considerations that should be given to conducting a well-controlled clinical study, if, indeed, clinical data is required.
What is GCP, and what does it mean to be GCP compliant? In order to take "good" to "great," it is important understand the conceptual framework that supports good clinical practice and apply that understanding in daily research activities. Download our latest whitepaper to learn how.
The goal of this whitepaper is to introduce you to the concept of the FAIR Shake™. Based on regulatory fact, as opposed to popular opinion, the FAIR Shake™ technique takes a complicated maze of requirements and breaks them down into four simple areas that can be applied to clinical research questions. Now you can navigate through the complexity of the regulatory framework in a very simple way.
While the investigations of drugs and devices have their differences, by design these differences are intended to accomplish the same goal: to safeguard those research participants while bringing safe and effective products to the market as quickly as possible. Understanding the similarities and appreciating the differences is important for clinical researchers who are involved in both drug and device trials.
As we continue in our series of analyzing warning letter findings, we move from clinical investigators to IRBs, assessing their level of compliance with 21 CFR Part 56. A random review of warning letters issued to IRBs in recent years showed 3 key areas in need of improvement; including written procedures, timeliness of continuing review, and adequate documentation. A few examples of these citations are provided.
With the trials IMARC has monitored, our experience has been that the FDA has begun inspecting clinical sites after the Sponsor submits their Premarket Approval Application (PMA), the application submitted to the FDA for approval of a Class III device. In this case, however, the FDA contacted one of the sites for a routine inspection months before the PMA was to be submitted. The site inspected was among the top enrollers in this particular study, and was an academic medical center. Some of the challenges presented at this particular site are included in this download.
IMARC's 2010 warning letter "report card" is in! After reviewing warning letters issued to investigators and sponsor-investigators in 2010 through the FDA's Bioresearch Monitoring Inspection Program, IMARC’s clinical monitoring team has assembled the following "TOP 10" list.
IMARC's 2009 warning letter "report card" is in! After reviewing warning letters issued to investigators and sponsor-investigators in 2009 through the FDA's Bioresearch Monitoring Inspection Program, IMARC’s clinical monitoring team has assembled the following "TOP 10" list.
