Medical Device CRO Blog | IMARC Research Whitepaper

Posted by John Lehmann on Thu, Mar 14, 2019

The Fundamentals of Good Clinical Research

ood Clinical Practice (GCP) is a foundation for all clinical research, driven by a desire to ensure everyone who participates in studies is given the protection they deserve. The fundamental principles of GCP have not changed since they were introduced more than 50 years ago. However, as the use of technology in clinical research has evolved to include electronic signatures, records and more, there are new considerations.

Topics: Good Clinical Practice, Clinical Research, IMARC Research Whitepaper

Posted by John Lehmann on Wed, Mar 14, 2018

What Is New In GCP

Clinical research professionals need to keep up to date with changes to the industry to ensure their studies remain compliant and human subjects are protected as research becomes more complex. Several important changes have taken place over recent years, including greater emphasis on risk-based and quality-focused thinking, as well as the increased use of electronic technologies to accomplish research activities.

Topics: GCP, IMARC Research Whitepaper

Posted by Brandy Chittester on Thu, Oct 05, 2017

How to Write a Great Monitoring Report

Writing monitoring reports is an important responsibility. A well-written monitoring report tells the story of your clinical trial to the FDA and helps facilitate inspections. However, this important task doesn’t often get the attention it deserves. Between scheduling visits, traveling and conducting the visits, it can fall down on a monitor’s priority list.

Topics: IMARC Research Whitepaper, Monitoring Report

Posted by John Lehmann on Thu, Mar 24, 2016

In Vitro Diagnostics: The Basics

It has been estimated that In Vitro Diagnostics (IVD) will play a role in around 70% of health care decisions, and market estimates predict the IVD market will be close to 75 billion dollars in 2010. The role of IVDs in health care decisions should only continue to grow as healthcare shifts away from a “one-size-fits-all” model. Furthermore, developments in technology and the scope and precision of some of these devices have led to the evolution of the IVD field and with it, the role the FDA has played in regulating these devices.

Topics: IVD, FDA, IMARC Research Whitepaper, In Vitro Diagnostics

Posted by John Lehmann on Fri, Jun 05, 2015

Risk Management Whitepaper

As the regulators continue to raise the bar for quality clinical research investigations, IMARC has released a whitepaper that discusses the principles of risk management and their application to clinical research.

Topics: FDA Guidance, Risk Management, IMARC Research Whitepaper

Posted by John Lehmann on Fri, Jun 03, 2016

Clinical Research Training Requirements

IMARC Research’s new whitepaper examines the similarities and differences between the current US regulations and places them within the context of any number of roles found within the realm of clinical research. While there are no direct references within the regulations as to what types and to what degree training is required, a well-developed training curriculum is a prerequisite for quality research.

Topics: Medical Devices, GCP/Regulatory Training, IMARC Research Whitepaper

Posted by John Lehmann on Wed, Mar 04, 2015

Understanding the Difference Between FDA Regulations and ISO 14155

As industry begins conducting more and more device trials globally, now more than ever it is crucial to understand the important differences that exist between the FDA’s regulations and the international standards of ISO 14155. IMARC Research has created a new whitepaper that highlights these differences.

Topics: Federal Regulations, ISO 14155, CFR 21, IMARC Research Whitepaper

Posted by John Lehmann on Wed, Mar 04, 2015

Laying the Regulatory Groundwork for a Successful Physician-Sponsored IDE Study

Please take time to review IMARC Research’s new whitepaper entitled “Conducting a Physician-Sponsored Investigational Device Exemption - Laying the Regulatory Groundwork for Success.” When a Sponsor-Investigator conducts a device study, it may be referred to as a Physician-Sponsored IDE (PS-IDE).

Topics: IMARC Research Whitepaper, Regulatory, Physician-Sponsored IDE Study, PS-IDE

Posted by Sandra Maddock on Wed, Mar 04, 2015

The Top 5 Complications of FDA Medical Device Trials

Topics: Medical Devices, Complicated Clinical Trials, FDA, IMARC Research Whitepaper

Posted by John Lehmann on Fri, Jun 03, 2016

Product Accountability in Clinical Trials- Why is it important?

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. Unless a product is approved under the appropriate regulations for a specific use, it cannot be commercialized for that indication. In clinical research the products are still investigational, and even in a hospital setting, these products are treated differently.

Topics: Product Accoutability, Clinical Research, IMARC Research Whitepaper

Posted by John Lehmann on Mon, Nov 06, 2017

Significant Risk/Non-Significant Risk Determination

Dr. Harvey Arbit of Arbit Consulting has penned a whitepaper for IMARC Research titled, “Significant Risk/Non-Significant Risk Determination and IDE Applicability.” Although the Medical Device Amendments were enacted on May 28, 1976, it still seems that after all these years there is confusion and misunderstanding regarding the process for determining if an investigational device is Significant Risk (SR) or Non-Significant Risk (NSR).

Topics: Dr. Harvey Arbit, Significant Risk, Non-Significant Risk, IMARC Research Whitepaper

Posted by John Lehmann on Fri, Jun 03, 2016

How to Tackle Complicated Clinical Trials

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. The path to FDA approval requires tremendous organizational skills and attention to detail to navigate; but with the right preparation and commitment to compliance, all of these challenges can be overcome.

Topics: FDA, Clinical Research, IMARC Research Whitepaper