Medical Device CRO Blog

Screening or Consent: Which Came First?

Posted by John Lehmann on Tue, May 05, 2015

 

The informed consent process is arguably one of the most important parts of a clinical research study. Fromthe Principles of ICH GCP: the rights, safety, and well-being of the trial subjects are the most important considerations and should prevail over interests of science and society. Proper informed consent ensures that the patient is aware of the risks and requirements of being in a research study and has voluntarily agreed to participate in research.  The regulations, CFR part 50 also cover the importance, rules and process of informed consent.

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Topics: Informed Consent, Research Coordinators, GCP

Clinical Research Training Fundamentals

Posted by John Lehmann on Tue, Apr 28, 2015

Proper training assures sponsors organizations that their research meets all the industry standards of compliance, and that their clinical studies will be conducted in a well-controlled, high quality manner that will withstand the rigors of regulatory inspection.

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Topics: IMARC University, Online Training, Training Fundamentals Checklist

FDA Still Honing Medical Device Regulatory Process

Posted by John Lehmann on Wed, Apr 22, 2015

Former FDA Commissioner Margaret Hamburg says FDA is still honing its medical device regulatory process so it strikes a balance between patient safety and industry’s desire to market their products. Speaking at the National Press Club in Washington D.C., which might be her last public appearance as commissioner. She indicated that she is not sure the U.S. or Europe have gotten the balance right yet.

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Topics: Margaret Hamburg, FDA, Medical Device Regulatory Process

How to Tackle Complicated Clinical Trials

Posted by John Lehmann on Thu, Apr 16, 2015

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.

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Topics: Medical Devices, Complicated Clinical Trials, Medical Device CRO, FDA

Product Accountability in Clinical Trials- Why is it important?

Posted by John Lehmann on Mon, Apr 06, 2015

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.

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Topics: Whitepaper, Product Accountability, IMARC Research, Clinical Trials

Final FDA Guidance: Medical Device Data Systems, Medical Image Storage Devices, and Medical Image Communications Devices

Posted by Emily Haglund on Fri, Apr 03, 2015

Recently, the FDA issued a final guidance document regarding medical device data systems, medical image storage devices, and medical image communications devices. The FDA also held a webinar in February 2015 to support this guidance document.

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Topics: Medical Device, FDA Guidance, Medical Image Storage Devices, Medical Image Communications Devices

5 Data Strategies for Medical Device Companies

Posted by John Lehmann on Wed, Apr 01, 2015

It’s without question that medical devices are becoming more and more advanced. These technological increases only continue to provide data, and lots of it! An article which asks, “Is The Medical Device Industry Ready for Big Data”- caught our attention and we’d like to know your thoughts, are medical device companies ready for what could be ahead?

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Topics: Medical Device Companies, HIPAA, Big Data

AdvaMed Provides FDA with its Own Priority List

Posted by John Lehmann on Fri, Mar 27, 2015

AdvaMed, the medical device trade group has never been shy about sharing its opinion with the FDA.  According to a recent article in Medical Device and Diagnostic Industry (MD+DI), AdvaMed has voiced its opinions on what priorities the medtech industry believes the FDA should prioritize.

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Why Good Clinical Practice is So Important

Posted by John Lehmann on Tue, Mar 24, 2015

In a report from the Institute of Medicine (IOM) was based on a workshop held with this focus: “Public Engagement and Clinical Trials.” In this report, IOM draws attention to the fact that many clinical trials are slow to enroll patients, and some studies never reach their recruitment number goal.

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Topics: Good Clinical Practice, Institute of Medicine, Tuskegee Syphilis Study, Ketek Trial, Medical Device CRO

The Declaration of Helsinki - 1964

Posted by Natalie Jarmusik on Thu, Mar 19, 2015

You may be familiar with IMARC Research’s History of Clinical Research (HCR). We recently released an eBook about it that briefly describes all of the images that currently make up the timeline. If you have visited our office, you may have also been given a guided tour of one of our most renowned resources. Due to the overwhelmingly positive feedback we have received, we will be highlighting each time point with a series of blogs that we plan to release over the course of the 2015 calendar year.

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Topics: Good Clinical Practice, Institute of Medicine, Tuskegee Syphilis Study, Ketek Trial