Medical Device CRO Blog

FDA Audit Prep

Posted by Mary Lewis on Tue, Dec 01, 2015

You’ve received “the call” from the FDA auditor.  After an understandable quick moment of panic, what should your next steps be?

At IMARC, we have participated in the audit preparation process for numerous sites who have been contacted for an FDA audit.  It is helpful for a site to know what the FDA auditor will use during their review.  In a past blog, we discussed a new document introducing a standardized Nonconformity Grading System, which was created by the former Global Harmonization Task Force (now re-named International Medical Device Regulators Forum) to assist regulatory authorities and auditing organizations. 

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Topics: Audit Prep, BIMO Checklist, FDA

10 Attributes of a Great Monitor

Posted by Brandy Chittester on Wed, Nov 25, 2015

Monitoring clinical trials at a high level requires a unique set of traits, skills, and abilities. While monitors often have diverse backgrounds and experiences, there are specific attributes that characterize great monitors and separate them from the rest of the pack. The following list identifies those attributes and explains why each is instrumental to clinical monitoring. This list is not ranked in any particular order and is not meant to be all inclusive; please share your thoughts!

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Topics: Medical Devices, Clinical Trials, Monitoring, 10 Attributes

IMARC Expand Service Offerings

Posted by John Lehmann on Thu, Nov 19, 2015

IMARC Research has launched independent oversight capabilities by adding Data Safety Monitoring Boards (DSMBs) and Clinical Events Committees (CECs) to its existing monitoring, auditing, training, project management and consulting services.

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Topics: Sandra Maddock, IMARC Research

What is the FDA Form 3674?

Posted by Shawn Kennedy on Thu, Nov 12, 2015

Recently, while on a monitoring visit for a physician sponsored IDE study in which IMARC was concurrently conducting a clinical audit, I was caught off guard by the question “do you know what the FDA Form 3674 is?”  I thought I had spent a good deal of my professional career working in the clinical research industry, I try my best to be a diligent student of the regulations and GCP guidelines, and even have tested my wits by passing the SOCRA certified clinical research professional exam.  However, I was stumped when it came to this mysterious form, albeit somewhat relieved that my co-monitor and the auditor that asked me were equally baffled by what it was.  At our auditor’s good suggestion, we took to finding the answer.  That night, she emailed FDAs FDAs for their input.  This is really a fantastic tool in and of itself if you have not utilized it, someone from FDA will respond to your questions regarding good clinical practice in the field of clinical research.

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Topics: 510(k) Program, Clinical Auditing, FDA, Form 3674

Expedited Review: Breakthrough Therapy

Posted by Ryan Begun on Thu, Nov 05, 2015

In the wake of the recent Ebola pandemic, we realize the importance of pushing drugs and pharmaceuticals through the FDA approval process as quickly as possible. From drug discovery to FDA approval, the average drug takes roughly ten years costing $2.6 billion dollars during the process. Delaying the drug from reaching market just one day can cost the Sponsor millions and potentially the lives of patients hindered by the condition the drug is to treat. With the pressing need for cures and treatments, an expedited approval has the potential to be advantageous for all. Over a series of blogs, I will review the four FDA expedited review programs.

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Topics: FDA, Expedited Review

ALCOA - The Best Way to Document Your Work

Posted by John Lehmann on Mon, Nov 02, 2015

 When documenting your research observations, it is important to remember the adage, “If it wasn’t documented, it wasn’t done”.  As research professionals, we have an obligation to uphold the highest ethical standards and make all possible efforts to comply with Good Clinical Practice. We must take credit for what we do - and to take credit for what we do, we must properly document our work.

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Topics: 21 CFR 58.130 (15), ALCOA Checklist, FDA

Financial Disclosure of Equity Interest

Posted by Brad Liebermann on Tue, Oct 27, 2015

The FDA evaluates the disclosure of financial information from clinical investigators to determine the reliability of data submitted to the FDA and identify steps to minimize the potential for bias. The value of an investigator’s financial interest in the sponsor may have the potential to increase if the product is approved. 21 CFR 54 states that investigators must disclose significant equity interest in the sponsor, any proprietary interest in the sponsor and significant payments of other sorts from the sponsor during the time the investigator is carrying out the study and for a period of one year following completion of the study.

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Topics: Draft Guidance, Financial Disclosure, FDA

New FDA Draft Guidance: Revised ICH Guidelines for Good Clinical Practice

Posted by Shawn Kennedy on Thu, Oct 22, 2015

Recently, FDA issued a new draft guidance document through their online email notification system regarding proposed revisions to the ICH GCP Guidelines for Good Clinical Practice.  The draft guidance, titled “E6 (R2) Good Clinical Practice,” is currently in what FDA calls “Step 2 of the ICH Process,” which means that it was released for feedback by the ICH Steering Committee on 11 June 2015 to the regulatory authorities of the ICH regions (the European Union, Japan, the USA, Canada, and Switzerland).  This is very exciting news for the clinical research community, as the ICH GCP Guidelines have not been updated since they were originally released nearly 20 years ago in 1996. 

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Topics: Good Clinical Practice, ICH GCP, Draft Guidance, FDA

The Post Market Surveillance Study

Posted by Leonard Basobas on Fri, Oct 16, 2015

 A police siren blares, but only for a brief moment indicating that the police officer just wanted to make his presence known.

In turn, your surprise quickly morphs into frustration as you see the flash of red and blue lights in your rear view mirror.  You pull to the side of the road.

“Do you know why I pulled you over?” the officer posits staring at a roll of papers in his hand.

“Honestly, I am at a loss sir?” you sarcastically reply.  “I just got on the highway to test out my new car, which is just off the assembly line, I might add, and I wasn’t even up to the speed limit yet.”

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Topics: FDA, Post Market Surveillance Study, Section 522

FDA Establishing a Patient Engagement Advisory Committee (PEAC)

Posted by Kelly Jasko on Mon, Oct 12, 2015

As we are in an era of “patient-centered” medical care, the focus of health care now enables patients to make choices regarding their physicians, hospitals, and treatment options.  The transparency of medical costs allow patients to “shop-around” for their healthcare preferences, and gone are the days of simply letting health care providers guide medical decisions.  In a recent article on the FDA’s website, they have fostered this idea and announced their first ever Patient Engagement Advisory Committee (PEAC). This committee is part of the FDA’s Patient Preference Initiative, which was launched in 2013, and marks an additional way to incorporate patients’ views on benefits and risks with those of the FDA’s scientists, engineers, and medical professionals.  

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Topics: FDA, Patient Engagement, PEAC