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FDAinspections_LP

Featured Resource

2019 FDA Warning Letters: Know Them So You Can Avoid Them

Each year, IMARC reviews the findings of FDA inspections to pinpoint top findings issued to clinical investigators.
This whitepaper reveals the top violations.
Download it now to discover what they are and how you can prevent them. 

Download Now

Resources Library

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

Role Based Courses
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Role Based Courses

Course Packages
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Course Packages

How IMARC University Works
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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

Monitoring at IMARC
Videos

Monitoring at IMARC

Monitoring Sell Sheet
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Monitoring Sell Sheet

The 5 C's of IMARC
Videos

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
Videos

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

Conducting Global Clinical Trials
Whitepapers

Conducting Global Clinical Trials

Good Clinical Practice Partnerships
Case Studies

Good Clinical Practice Partnerships

Pre-PMA FDA Inspection
Case Studies

Pre-PMA FDA Inspection

IRB + 123 = Patient Protection
Checklists and Guidelines

IRB + 123 = Patient Protection

Daily Documentation Essentials
Publications

Daily Documentation Essentials

IMARC Research Expands Staff
Press Releases

IMARC Research Expands Staff

IMARC Reseach Names Assistant Director
Press Releases

IMARC Reseach Names Assistant Director

IMARC Signs Agreement with European CRO
Press Releases

IMARC Signs Agreement with European CRO

IMARC Expands Service Offerings
Press Releases

IMARC Expands Service Offerings

Gxp Lifeline: Good Clinical Practice
Publications

Gxp Lifeline: Good Clinical Practice

Medical Device Clinical Trials
Publications

Medical Device Clinical Trials

2009 Top 10 FDA Warning Letter Findings
Checklists and Guidelines

2009 Top 10 FDA Warning Letter Findings

Trust The Process
Case Studies

Trust The Process

Blueprint for Success
Checklists and Guidelines

Blueprint for Success

Clinical Trials: Drugs vs. Devices
Presentations

Clinical Trials: Drugs vs. Devices

501k Clinical Data Requirements
Publications

501k Clinical Data Requirements

Ensuring Proper Training
Publications

Ensuring Proper Training

IMARC Research Receives ISO 9001:2008
Press Releases

IMARC Research Receives ISO 9001:2008

Cell Therapy: The Fourth Pillar of Healthcare
Checklists and Guidelines

Cell Therapy: The Fourth Pillar of Healthcare

Risk Management in Clinical Research
Publications

Risk Management in Clinical Research

IMARC University Course Catalog
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IMARC University Course Catalog

Running a Clinical Trial
Presentations

Running a Clinical Trial

Building a Basic Good Clinical Practice Foundation
Publications

Building a Basic Good Clinical Practice Foundation

A 4-Point Training Program to Navigate Through Regulations
Presentations

A 4-Point Training Program to Navigate Through Regulations

Centralized vs. OnSite Monitoring Presentation
Presentations

Centralized vs. OnSite Monitoring Presentation

Regulatory Quality Solutions
Presentations

Regulatory Quality Solutions

Risk-Based Monitoring: A Checklist
Checklists and Guidelines

Risk-Based Monitoring: A Checklist

2010 Top 10 FDA Warning Letter Findings
Checklists and Guidelines

2010 Top 10 FDA Warning Letter Findings

Good Clinical Practice
Whitepapers

Good Clinical Practice

510k Current Status Considerations
Whitepapers

510k Current Status Considerations

Documentation in Device Studies
Whitepapers

Documentation in Device Studies

2011 Top 10 FDA Warning Letters
Checklists and Guidelines

2011 Top 10 FDA Warning Letters

Significant Risk/Non-Significant Risk Determination
Whitepapers

Significant Risk/Non-Significant Risk Determination

Is Your Trial Complex?
Whitepapers

Is Your Trial Complex?

Centralized vs. OnSite Monitoring Whitepaper
Whitepapers

Centralized vs. OnSite Monitoring Whitepaper

How to Improve Site Compliance
Whitepapers

How to Improve Site Compliance

Regulations Revelations
Whitepapers

Regulations Revelations

Product Accountability
Whitepapers

Product Accountability

Selecting Outstanding Sites
Whitepapers

Selecting Outstanding Sites

5 Factors to Consider When Choosing a CRO
Whitepapers

5 Factors to Consider When Choosing a CRO

Conducting a Physician-Sponsored Investigational Device Exemption
Whitepapers

Conducting a Physician-Sponsored Investigational Device Exemption

2013 Top FDA Warning Letter Findings
Checklists and Guidelines

2013 Top FDA Warning Letter Findings

Misconduct in Research
Whitepapers

Misconduct in Research

Risk Management in Clinical Research
Whitepapers

Risk Management in Clinical Research

Clinical Research Training Requirements
Whitepapers

Clinical Research Training Requirements

2014 Top 10 Warning Letter Findings
Checklists and Guidelines

2014 Top 10 Warning Letter Findings

In Vitro Diagnostics: The Basics
Whitepapers

In Vitro Diagnostics: The Basics

5 Hurdles to Overcome
Checklists and Guidelines

5 Hurdles to Overcome

Clinical Research Safety Checklist
Checklists and Guidelines

Clinical Research Safety Checklist

Elements of a Regulatory Inspection
Whitepapers

Elements of a Regulatory Inspection

2015 Top Warning Letter Findings
Checklists and Guidelines

2015 Top Warning Letter Findings

Adding Value to a Study
Checklists and Guidelines

Adding Value to a Study

A Handy Guide to Medical Device Classification
Infographics

A Handy Guide to Medical Device Classification

Guidance for Ensuring Your Clinical Study
Checklists and Guidelines

Guidance for Ensuring Your Clinical Study

Guide to Launching a Clinical Research Training Program
Checklists and Guidelines

Guide to Launching a Clinical Research Training Program

Choosing a Skilled Clinical Research Project Manager
Checklists and Guidelines

Choosing a Skilled Clinical Research Project Manager

How to Hire a Compliance-Minded CRO
Whitepapers

How to Hire a Compliance-Minded CRO

Building the Business Case for Clinical Research Training
Checklists and Guidelines

Building the Business Case for Clinical Research Training

Why Conduct Clinical Vendor Audits?
Infographics

Why Conduct Clinical Vendor Audits?

5 Keys to Choosing a Medical Device CRO
Infographics

5 Keys to Choosing a Medical Device CRO

ALCOA-C Checklist
Checklists and Guidelines

ALCOA-C Checklist

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

When to Enlist a DSMB or CEC for Your Clinical Trial

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

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

How to Respond to a Form 483
Whitepapers

How to Respond to a Form 483

Top 3 Reasons for FDA Warning Letters
Checklists and Guidelines

Top 3 Reasons for FDA Warning Letters

Top 5 Reasons an FDA Warning Letters is Issued to an IRB
Checklists and Guidelines

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

Working with IMARC: Your Partners in Compliance
Checklists and Guidelines

Working with IMARC: Your Partners in Compliance

Ensuring Compliance Throughout the Clinical Trial Lifecycle
Videos

Ensuring Compliance Throughout the Clinical Trial Lifecycle

Clinical Trial Lifecycycle
Checklists and Guidelines

Clinical Trial Lifecycycle

How to Write a Great Monitoring Report
Whitepapers

How to Write a Great Monitoring Report

Checklist: Writing a Great Monitoring Report
Checklists and Guidelines

Checklist: Writing a Great Monitoring Report

Auditing vs. Monitoring in Clinical Research Studies
Whitepapers

Auditing vs. Monitoring in Clinical Research Studies

Drugs vs. Devices The Difference is in the Details
Whitepapers

Drugs vs. Devices The Difference is in the Details

Research Coordinator Support
Whitepapers

Research Coordinator Support

Avoiding IRB Warning Letters
Whitepapers

Avoiding IRB Warning Letters

Giving Your Studies a Fair Shake
Whitepapers

Giving Your Studies a Fair Shake

Utilizing a Quality Systems Approach
Whitepapers

Utilizing a Quality Systems Approach

The History of Clinical Research
Whitepapers

The History of Clinical Research

Clinical Support Service Pain Points
Checklists and Guidelines

Clinical Support Service Pain Points

Outsourcing Safety Management
Checklists and Guidelines

Outsourcing Safety Management

IMARC Research Expands Minneapolis Office
Press Releases

IMARC Research Expands Minneapolis Office

What's New in GCP?
Whitepapers

What's New in GCP?

Will Your TMF Pass the Test?
Checklists and Guidelines

Will Your TMF Pass the Test?

The Value of an Electronic Trial Master File Audit
Infographics

The Value of an Electronic Trial Master File Audit

5 Guidelines for Writing a Useful Clinical Monitoring Report
Publications

5 Guidelines for Writing a Useful Clinical Monitoring Report

Ensuring Quality In Medical Device Trials
Publications

Ensuring Quality In Medical Device Trials

Drugs vs Devices Comparison
Checklists and Guidelines

Drugs vs Devices Comparison

Monitoring as a Mindset
Whitepapers

Monitoring as a Mindset

A Guide To Source Data Extraction and Verification
Checklists and Guidelines

A Guide To Source Data Extraction and Verification

10 Attributes of an A+ Clinical Monitoring Service
Checklists and Guidelines

10 Attributes of an A+ Clinical Monitoring Service

5 Steps to Make Your Monitoring Efforts Matter
Checklists and Guidelines

5 Steps to Make Your Monitoring Efforts Matter

Comprehensive Training Design for CRAs and CRCs
Whitepapers

Comprehensive Training Design for CRAs and CRCs

Save Money With A Remote Trial Master File Review
Videos

Save Money With A Remote Trial Master File Review

2017 FDA Inspections: Findings for Clinical Investigators
Checklists and Guidelines

2017 FDA Inspections: Findings for Clinical Investigators

Good Clinical Research Training
Checklists and Guidelines

Good Clinical Research Training

Training Fundamentals
Checklists and Guidelines

Training Fundamentals

IMARC Research Earns New Quality Certification
Press Releases

IMARC Research Earns New Quality Certification

IMARC Celebrates 20 Years of Supporting Clinical Research
Press Releases

IMARC Celebrates 20 Years of Supporting Clinical Research

Clinical Trial Project Management
Whitepapers

Clinical Trial Project Management

The History of Clinical Research
Videos

The History of Clinical Research

Fundamentals of GCP
Whitepapers

Fundamentals of GCP

GCP Auditing: Take a quality snapshot of your clinical study
Checklists and Guidelines

GCP Auditing: Take a quality snapshot of your clinical study

IMARC Research Focuses On Strategic Growth in 2020
Press Releases

IMARC Research Focuses On Strategic Growth in 2020

Give Your Studies a FAIR Shake
Videos

Give Your Studies a FAIR Shake

Clinical Study Clean-up
Whitepapers

Clinical Study Clean-up

FDA Inspections Findings
Whitepapers

FDA Inspections Findings

Navigating EU MDR
Whitepapers

Navigating EU MDR

Understanding the MDR & IVDR
Checklists and Guidelines

Understanding the MDR & IVDR

The 6 Essential Strategies for your MDR Survival
Presentations

The 6 Essential Strategies for your MDR Survival

Preparing for the New EU Medical Device Regulation
Videos

Preparing for the New EU Medical Device Regulation

Training Guide & Course Catalog
Checklists and Guidelines

Training Guide & Course Catalog

Preparing for a BIMO FDA Inspection
Whitepapers

Preparing for a BIMO FDA Inspection

Hiring a CRO - 20 Questions to Ask
Checklists and Guidelines

Hiring a CRO - 20 Questions to Ask

Budgeting for a CRO
Whitepapers

Budgeting for a CRO

5 Ways to Maintain Compliance During COVID-19
Checklists and Guidelines

5 Ways to Maintain Compliance During COVID-19

Remote Enrollment in a Non-Significant Risk Device Study During the COVID-19 Pandemic
Case Studies

Remote Enrollment in a Non-Significant Risk Device Study During the COVID-19 Pandemic

How to Safely Reopen Your Clinical Research Sites
Checklists and Guidelines

How to Safely Reopen Your Clinical Research Sites

What Does It Mean To Be Audit Ready
Whitepapers

What Does It Mean To Be Audit Ready

2019 FDA Warning Letters
Whitepapers

2019 FDA Warning Letters

6 Emerging Medical Device Trends
Checklists and Guidelines

6 Emerging Medical Device Trends

Save Time and Money With Remote Services
Videos

Save Time and Money With Remote Services

How to Implement a Clinical Research CAPA
Whitepapers

How to Implement a Clinical Research CAPA

On-Demand Webcast: Prioritizing in the New Normal
Videos

On-Demand Webcast: Prioritizing in the New Normal

Checklist: How to Implement a Clinical Research CAPA
Checklists and Guidelines

Checklist: How to Implement a Clinical Research CAPA
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