Medical Device CRO Blog

Trust the Process – A Case Study

Posted by John Lehmann on Tue, Aug 25, 2015

Merriam Webster defines a case study as a published report about a person, group, or situation that has been studied over time; also : a situation in real life that can be looked at or studied to learn about something.  Case studies can be useful to help highlight how to handle a particular situation, including the eventual outcome.

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Topics: FDA Audit, FDA Inspection, BIMO

Back Translations

Posted by John Lehmann on Wed, Aug 19, 2015

On a recent monitoring visit, the coordinator asked an IMARC monitor if the study sponsor could have their consent translated into Spanish. However, the site had one caveat – their IRB also required a “back translation” of the translated consent. Why would the IRB require this back translation?

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Topics: Consent, Back Translation, Section 50.20

Why Do We Need to Audit?

Posted by John Lehmann on Thu, Aug 13, 2015

How is auditing different than monitoring? Why do we need to audit? Since these questions are so often asked, we decided to create a graphic that will help you understand when to consider an audit. In short, auditing brings an independent, quality assurance perspective to the clinical research landscape Investigational sites, sponsors, and vendors benefit from high-level process assessments and improvements. Experienced auditors leverage extensive training to help ensure subject safety, data integrity, and protocol and regulatory compliance.

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Topics: GCP, Auditing, Quality Assurance

Risk Management in Clinical Research

Posted by John Lehmann on Mon, Aug 10, 2015

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.

The guidance documents for good clinical practice (GCP), ICH E6 and ISO14155, state the sponsor is responsible for quality assurance and quality control within a clinical trial. To achieve this, the sponsor must invest resources into these different aspects of a clinical trial. One specific aspect of integrating quality involves how risks are approached and managed throughout the course of a study. Both the Food and Drug Administration (FDA) and the European Medicines Agency (EMA) released documents in 2013 focused on the integration of traditionally development and manufacturing quality principles, including risk-based approaches into the clinical research industry. FDA’s “Guidance for Industry: Oversight of Clinical Investigations—A Risk-Based Approach to Monitoring” and EMA’s “Reflection paper on risk based quality management in clinical trials” both describe how regulators now expect a quality, risk-based approach when conducting clinical research. These documents are examples of the shift toward quality techniques underway within industry when developing, initiating, and executing studies.

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Topics: Risk Management, IMARC Whitepaper, FDA

FDA Prioritizes Combo Product Reforms

Posted by John Lehmann on Wed, Aug 05, 2015

Both companies and the FDA continue to be frustrated with the mismatches between drug and deviceFDA_Prioritizes_Combo_Product_Reforms-1 regulations along with the communication challenges between the product centers that lead to inefficiencies.  FDA officials are signaling that the combination products review process is ready for reform and the 2017 user fee authorizations offer a good opportunity to make much needed changes.

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Topics: Jeffrey Shuren, Combination Products, FDA, Robert Califf

5 Steps to Make Your Monitoring Efforts Matter

Posted by John Lehmann on Wed, Jul 29, 2015

Monitoring remains our main focus at IMARC Research.  As discussed in a previous whitepaper, “Monitoring as a Mindset”, monitoring is defined by the FDA as the act of overseeing an investigation.  Specifically noted in 21 CFR 812.43, sponsors are required to select monitors qualified by training and experience.  In addition, 812.46 states that monitoring investigations should include securing compliance at investigative sites, whenever necessary.

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Topics: 21 CFR, IMARC Whitepaper, FDA, Monitoring

FDA Regulations - Title 21: 1981

Posted by Shawn Kennedy on Wed, Jul 22, 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 2014-2015 calendar years.

In today’s day and age, it is a widely accepted and understood requirement that conducting clinical research for investigational new drugs and devices in the United States means that you will be responsible for following the FDA regulations.  The terms, “according to the regulations, “or “according to the regs,” are used commonly, as we all have grown accustomed to these seemingly intuitive laws that govern the practice of clinical research.  However, not too long ago, the regulations we freely refer to now did not exist.  It wasn’t until after the 1979 Belmont Report, that FDA and the Department of Health and Human Services formally revised regulations for human subject protections by creating Title 21 - Food and Drugs

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Topics: History of Clinical Research Timeline, FDA Regulations, Code of Federal Regulations (CFR) Title 21

Ensuring Proper Training for Clinical Research Staff

Posted by John Lehmann on Mon, Jul 20, 2015

Please take time to view Sandra Maddock’s  article “ Ensuring Proper Training for Clinical Research Staff in Less Time” that was recently posted on GxP Lifeline.  With the clinical research industry experiencing continued growth,It only makes sense then that clinical research professionals need continuing education to keep up with a rapidly evolving industry.

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Topics: Sandra Maddock, Training, GxP Lifeline, Clinical Research

Inclusion and Exclusion - Behind the Scenes

Posted by John Lehmann on Wed, Jul 15, 2015

Investigational plans, or protocols, are developed with what authors believe are clear inclusion and exclusion criteria that must be confirmed prior to the initiation of any investigational treatment or test.  There are certain inclusion criteria that are common including an age range, willingness to provide consent and adhere to the study schedule, and particular condition or diagnosis. Common exclusion criteria include a past medical diagnosis, excluded treatments or medications, or family history of a certain disease. According to 21 CRF 812.110 (b), it is the investigator’s responsibility to conduct the trial according to the investigational plan and therefore, adequately review medical history, interview the subject, and obtain labs or imaging to confirm that all inclusion and no exclusion criteria are met..

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Topics: Inclusion Criteria, Exclusion Criteria, 21 CRF 812.110 (b)

Site Selection - What to Look For?

Posted by Ashton Steinhagen on Thu, Jul 09, 2015

Selecting clinical sites for research purposes may be a difficult and seemingly overwhelming task  for a sponsor.  Familiarity with a site might help with selection, but multiple contributing factors can influence whether or not a site is ultimately chosen.  Choosing the wrong sites could have a detrimental effect on the study including:

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Topics: Sponsors, Site Selection, FDA