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Feel free to download and share whitepapers and publications that are relevant to your area of clinical research.

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Role Based Courses

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Course Packages

How IMARC University Works
Video

How IMARC University Works

Why Choose IMARC University
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Why Choose IMARC University

What is IMARC University
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What is IMARC University

Training Sell Sheet
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Training Sell Sheet

Site Support Sell Sheet
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Site Support Sell Sheet

Safety Monitoring Sell Sheet
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Safety Monitoring Sell Sheet

Project Management Sell Sheet
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Project Management Sell Sheet

Video

Monitoring at IMARC

Monitoring Sell Sheet
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Monitoring Sell Sheet

The 5 C's of IMARC
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The 5 C's of IMARC

The People of IMARC
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The People of IMARC

The Story of IMARC
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The Story of IMARC

General Brochure
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General Brochure

Fair Shake Sell Sheet
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Fair Shake Sell Sheet

Executive Summary
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Executive Summary

Consulting Sell Sheet
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Consulting Sell Sheet

Cardiac Trials Video
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Cardiac Trials Video

Cardiovascular Expertise Sell Sheet
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Cardiovascular Expertise Sell Sheet

Auditing at IMARC
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Auditing at IMARC

Auditing Sell Sheet
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Auditing Sell Sheet

Good Clinical Practice Partnerships
Checklist

Good Clinical Practice Partnerships

Pre-PMA FDA Inspection
Case Study

Pre-PMA FDA Inspection

IRB + 123 = Patient Protection
Checklist

IRB + 123 = Patient Protection

Daily Documentation Essentials
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Daily Documentation Essentials

IMARC Research Expands Staff
Press Release

IMARC Research Expands Staff

IMARC Reseach Names Assistant Director
Press Release

IMARC Reseach Names Assistant Director

IMARC Signs Agreement with European CRO
Press Release

IMARC Signs Agreement with European CRO

IMARC Expands Service Offerings
Press Release

IMARC Expands Service Offerings

Gxp Lifeline: Good Clinical Practice
Publication

Gxp Lifeline: Good Clinical Practice

Medical Device Clinical Trials
Publication

Medical Device Clinical Trials

2009 Top 10 FDA Warning Letter Findings
Guide

2009 Top 10 FDA Warning Letter Findings

Trust The Process
Case Study

Trust The Process

Blueprint for Success
Guide

Blueprint for Success

Clinical Trials: Drugs vs. Devices
Presentation

Clinical Trials: Drugs vs. Devices

501k Clinical Data Requirements
Publication

501k Clinical Data Requirements

Ensuring Proper Training
Publication

Ensuring Proper Training

IMARC Research Receives ISO 9001:2008
Press Release

IMARC Research Receives ISO 9001:2008

Cell Therapy: The Fourth Pillar of Healthcare
Checklist

Cell Therapy: The Fourth Pillar of Healthcare

Risk Management in Clinical Research
Publication

Risk Management in Clinical Research

IMARC University Course Catalog
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IMARC University Course Catalog

Running a Clinical Trial
Presentation

Running a Clinical Trial

Building a Basic Good Clinical Practice Foundation
Publication

Building a Basic Good Clinical Practice Foundation

A 4-Point Training Program to Navigate Through Regulations
Presentation

A 4-Point Training Program to Navigate Through Regulations

Centralized vs. OnSite Monitoring Presentation
Presentation

Centralized vs. OnSite Monitoring Presentation

Regulatory Quality Solutions
Presentation

Regulatory Quality Solutions

Risk-Based Monitoring: A Checklist
Checklist

Risk-Based Monitoring: A Checklist

2010 Top 10 FDA Warning Letter Findings
Guide

2010 Top 10 FDA Warning Letter Findings

Good Clinical Practice
Whitepaper

Good Clinical Practice

510k Current Status Considerations
Whitepaper

510k Current Status Considerations

Documentation in Device Studies
Whitepaper

Documentation in Device Studies

2011 Top 10 FDA Warning Letters
Guide

2011 Top 10 FDA Warning Letters

Significant Risk/Non-Significant Risk Determination
Whitepaper

Significant Risk/Non-Significant Risk Determination

Is Your Trial Complex?
Whitepaper

Is Your Trial Complex?

Centralized vs. OnSite Monitoring Whitepaper
Whitepaper

Centralized vs. OnSite Monitoring Whitepaper

How to Improve Site Compliance
Whitepaper

How to Improve Site Compliance

Regulations Revelations
Whitepaper

Regulations Revelations

Product Accountability
Whitepaper

Product Accountability

Selecting Outstanding Sites
Whitepaper

Selecting Outstanding Sites

5 Factors to Consider When Choosing a CRO
Whitepaper

5 Factors to Consider When Choosing a CRO

Conducting a Physician-Sponsored Investigational Device Exemption
Whitepaper

Conducting a Physician-Sponsored Investigational Device Exemption

2013 Top FDA Warning Letter Findings
Guide

2013 Top FDA Warning Letter Findings

Conducting Global Clinical Trials
Whitepaper

Conducting Global Clinical Trials

Misconduct in Research
Whitepaper

Misconduct in Research

Guide

GCP Auditing: Take a quality snapshot of your clinical study

Risk Management in Clinical Research
Whitepaper

Risk Management in Clinical Research

Clinical Research Training Requirements
Whitepaper

Clinical Research Training Requirements

2014 Top 10 Warning Letter Findings
Guide

2014 Top 10 Warning Letter Findings

In Vitro Diagnostics: The Basics
Whitepaper

In Vitro Diagnostics: The Basics

5 Hurdles to Overcome
Guide

5 Hurdles to Overcome

Clinical Research Safety Checklist
Checklist

Clinical Research Safety Checklist

Elements of a Regulatory Inspection
Whitepaper

Elements of a Regulatory Inspection

2015 Top Warning Letter Findings
Guide

2015 Top Warning Letter Findings

Adding Value to a Study
Guide

Adding Value to a Study

A Handy Guide to Medical Device Classification
Infographic

A Handy Guide to Medical Device Classification

Guidance for Ensuring Your Clinical Study
Guide

Guidance for Ensuring Your Clinical Study

Guide to Launching a Clinical Research Training Program
Guide

Guide to Launching a Clinical Research Training Program

Choosing a Skilled Clinical Research Project Manager
Checklist

Choosing a Skilled Clinical Research Project Manager

How to Hire a Compliance-Minded CRO
Whitepaper

How to Hire a Compliance-Minded CRO

Building the Business Case for Clinical Research Training
Guide

Building the Business Case for Clinical Research Training

Why Conduct Clinical Vendor Audits?
Infographic

Why Conduct Clinical Vendor Audits?

5 Keys to Choosing a Medical Device CRO
Infographic

5 Keys to Choosing a Medical Device CRO

ALCOA-C Checklist
Checklist

ALCOA-C Checklist

When to Enlist a DSMB or CEC for Your Clinical Trial
Infographic

When to Enlist a DSMB or CEC for Your Clinical Trial

Strategies for Auditors to Prepare Clinical Research Personnel For a Regulatory Inspection
Presentation

Strategies for Auditors to Prepare Clinical Research Personnel For a Regulatory Inspection

How to Respond to a Form 483
Whitepaper

How to Respond to a Form 483

Top 3 Reasons for FDA Warning Letters
Guide

Top 3 Reasons for FDA Warning Letters

Top 5 Reasons an FDA Warning Letters is Issued to an IRB
Guide

Top 5 Reasons an FDA Warning Letters is Issued to an IRB

Working with IMARC: Your Partners in Compliance
Guide

Working with IMARC: Your Partners in Compliance

Ensuring Compliance Throughout the Clinical Trial Lifecycle
Video

Ensuring Compliance Throughout the Clinical Trial Lifecycle

Clinical Trial Lifecycycle
Guide

Clinical Trial Lifecycycle

How to Write a Great Monitoring Report
Whitepaper

How to Write a Great Monitoring Report

Checklist: Writing a Great Monitoring Report
Checklist

Checklist: Writing a Great Monitoring Report

Auditing vs. Monitoring in Clinical Research Studies
Whitepaper

Auditing vs. Monitoring in Clinical Research Studies

Drugs vs. Devices The Difference is in the Details
Whitepaper

Drugs vs. Devices The Difference is in the Details

Research Coordinator Support
Whitepaper

Research Coordinator Support

Avoiding IRB Warning Letters
Whitepaper

Avoiding IRB Warning Letters

Giving Your Studies a Fair Shake
Whitepaper

Giving Your Studies a Fair Shake

Utilizing a Quality Systems Approach
Whitepaper

Utilizing a Quality Systems Approach

The History of Clinical Research
Whitepaper

The History of Clinical Research

Guide

Clinical Support Service Pain Points

Checklist

Outsourcing Safety Management

Press Release

IMARC Research Expands Minneapolis Office

Whitepaper

What's New in GCP?

Checklist

Will Your TMF Pass the Test?

Infographic

The Value of an Electronic Trial Master File Audit

Publication

5 Guidelines for Writing a Useful Clinical Monitoring Report

Publication

Ensuring Quality In Medical Device Trials

Guide

Drugs vs Devices Comparison

Whitepaper

Monitoring as a Mindset

Checklist

A Guide To Source Data Extraction and Verification

Checklist

10 Attributes of an A+ Clinical Monitoring Service

Guide

5 Steps to Make Your Monitoring Efforts Matter

Whitepaper

Comprehensive Training Design for CRAs and CRCs

Video

Save Money With A Remote Trial Master File Review

Guide

2017 FDA Inspections: Findings for Clinical Investigators

Checklist

Good Clinical Research Training

Checklist

Training Fundamentals

Press Release

IMARC Research Earns New Quality Certification

Press Release

IMARC Celebrates 20 Years of Supporting Clinical Research

Whitepaper

Clinical Trial Project Management

At IMARC, we proactively provide information devoted to various areas of clinical research, making it easier for you to navigate through the regulations. If you have any thoughts regarding one of our papers or ideas on a relevant topic, please contact us.
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