Whitepapers
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:
Research Coordinator Support Whitepaper
IMARC Research’s whitepaper investigates how remote clinical research coordinator support for data entry could potentially decrease cost delays in data submission, increase compliance, and increase safety vigilance, ultimately helping to bring innovative products to market sooner.
Previous Whitepapers:
2014 Top 10 Warning Letter Findings
For the sixth consecutive year, IMARC is presenting its Top 10 Warning Letter Findings for your review. In April 2015, the FDA released the BIMO metrics for 2014. These statistics are based on their findings from 1326 clinical research audits in the US and abroad.
Drugs vs. Devices the Difference is in the Details
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.
Clinical Research Training Requirements
Taking responsibility for ensuring “adequate qualifications” among all roles is something that is gaining momentum. By identifying training needs proactively through the use of a training matrix or training plan, and then implementing via a tailored approach, sponsors and CROs can exceed the industry requirement of “adequate qualifications”. This can help ensure a well-controlled study that results in protected patients and evaluable data.
Risk Management in Clinical Research: Process Development and Application
Risk management strategies can be applied to the clinical research industry. This investment will save time, resources, and likely eliminate, prevent, and/or minimize subject safety and data integrity risks.
GCP Auditing: Take a quality snapshot of your clinical study
Auditing brings an independent, quality assurance perspective to the clinical research landscape. Investigational sites, sponsors, and vendors benefit from high-level process assessments and improvements. Auditors leverage extensive training and experience to help ensure subject safety, data integrity, and protocol and regulatory compliance.
Misconduct in Research: Room to Improve
The history of clinical research is often studied as an important foundation for understanding the principles that guide modern human subjects research. This whitepaper can show you where unfortunate misconduct instances have occurred and the areas for improvement.
Conducting Global Clinical Research Trials
With a focus specifically on clinical investigators, this white paper will examine common findings from FDA inspections done both in the US and internationally, and highlight some differences between 21 CFR and ISO 14155 related to those findings that would be beneficial for study teams to know.
10 Attributes of an A+ Clinical Monitoring Service
Choosing the right clinical monitoring organization can be a challenge. IMARC Research’s core business is clinical monitoring. This is the foundation of the company and has helped forge our reputation and fuel our growth. So what differentiates our monitoring services from our competitors?
5 Steps to Make Your Monitoring Efforts Matter
What 5 steps can be taken to ensure monitoring goals are achieved? The goals of monitoring should include identifying and addressing non-compliance; improving quality and promoting high standards; and identifying research misconduct or fraud. Learn more by downloading our whitepaper today.
2013 Top FDA Warning Letter Findings
For Clinical Investigators, Sponsors and IRBs As we have done the past several years, IMARC has scoured the 2013 warning letters posted on the FDA’s website to compile the top findings for investigators. This year, we took a look at the top findings for Sponsors and IRBs as well!
The History of Clinical Research
IMARC Research commissioned a timeline of artwork, compiled within this eBook, to pay tribute to those who courageously participated in clinical research, both willingly and unwillingly, to recognize the good that has come out of the atrocities, to highlight some major achievements that would not have been possible without clinical trials, and to serve as a reminder to all of us that as we write our chapter in clinical research history.
Conducting a Physician-Sponsored Investigational Device Exemption: Laying the Regulatory Groundwork for Success
Chaos can sometimes ensue when one begins down the path of a PS-IDE. This white paper makes sense of that chaos by providing a brief overview of initiating a PS-IDE, the responsibilities of the investigator, the additional sponsor responsibilities assumed by the Sponsor-Investigator, and a thoughtful discussion on the records and reports of the Sponsor-Investigator.
5 Factors to Consider When Choosing a CRO for your Cardiovascular Clinical Trial
Choosing the right Contract Research Organization (CRO) for your CV clinical trial is imperative. Clinical trials conducted in the Cardiovascular (CV) arena are challenging, first and foremost, due to the variety of underlying disease states and conditions that affect a majority of potential trial participants. Here, we expand on five factors you should consider when choosing a CRO for your CV clinical trial.
Selecting Outstanding Sites
Learn more about an often underrated, yet important, part of the clinical research process.
Selecting investigators and sites is a very important part of the clinical research process as many factors depend on those individuals navigating the day-to-day of the journey to approval.
Auditing vs Monitoring in Clinical Research Studies
Learn how the two functions can have an additive rather than redundant impact on quality.
The purpose of this whitepaper will be to define monitoring and auditing, compare and contrast them, and propose that the combination of monitoring and auditing in a clinical trial setting can have an additive impact on the overall quality of a clinical trial.
Product Accountability in Clinical Trials
The Responsibility to Know Your Regs
In order for a new medical product to reach patients it must first be proven safe and effective and then be approved for use by the governing regulatory body. Clinical trials are the vehicle to bring these innovative technologies to patients and evaluate them in support of regulatory approval.
Regulations Revelations
Learn about some of our "ah-ha"! moments in previous clinical trials:
When a monitor has a tiny epiphany while working through a difficult compliance issue with a site, or an ‘Ah-ha!’ moment, we call that a ‘Regulation Revelation.’
How to Improve Site Compliance
Emphasize the research coordinator
When focusing on site compliance, there are many factors to consider. Although it is the Investigator who is responsible for the conduct of the study, there is a larger team at work to complete all the required activities.
Centralized vs. OnSite Monitoring
Understanding Risk-Based Approach to Monitoring
While many ask how risk-based approaches may reduce the costs of clinical studies by requiring less on-site monitoring of data, it's also important to ask what the risk is for NOT going on site. This whitepaper will guide you through the various aspects of what a monitor does on site, and how this affects monitoring, centralized monitoring and onsite monitoring.
Is Your Trial Complex?
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 taken 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.
Risk Determination
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.
2011 Top 10 FDA Warning Letter Findings
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.
Documentation in Devices
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.
Monitoring as a Mindset
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.
510(k) Current Status & Considerations
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.
Good Clinical Practice Download
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.
Giving Studies a "Fair Shake®"
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.
Avoiding IRB Warning Letters
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.
2010 FDA Warning Letter Findings for Clinical Investigators
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.
2009 FDA Warning Letter Findings for Clinical Investigators
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.
