In today’s business environment, it’s important to have reliable partners who can help you achieve your business goals and objectives. In clinical research, this is especially true. One proactive way to ensure your trial partners are meeting your standards is to conduct vendor audits. Clinical vendor audits assess the performance of the multi-faceted service delivery […]
IMARC
Revisions to the common rule
U.S. federal regulations governing the protection of human subjects in research have been in existence for more than 30 years. The Department of Health, Education, and Welfare first published regulations for the protection of human subjects in 1974, and the Department of Health and Human Services (HHS) revised them in the early 1980s. To promote […]
Volunteering for clinical research: what you need to know about the informed consent process
Medical research has led to many important medical discoveries that make our lives better. When medical research studies are completed, researchers can share the information with the medical community around the world at conferences or via peer-reviewed journals; and the results of these studies often help doctors provide better and more improved care to their […]
Building the business case for clinical research training
Most clinical research study sponsors recognize that having a properly trained research staff is key to ensuring compliance and bringing their device to market faster. The question is, how do you implement an effective training program that achieves your organization’s desired goals? This paper addresses the three Bs – buy-in, bandwidth and budget – and […]
The ICH E6(R2) Addendum: An intro to the what and why of the changes
By Katie Mitchell Since finalization in May of 1996, the Guideline for Good Clinical Practice E6(R1) produced by the International Conference on Harmonization (ICH), has provided clinical trial research with a set of procedural standards to ensure quality data and protection of human subjects. The document has continued to be a guiding presence in the industry […]
The history of clinical research
For research professionals involved in clinical trials, there is an immense responsibility of protecting human subjects, but history has taught us, unethical practice and disregard for the well-being of human subjects has occurred and will continue to occur. Ensuring accurate and credible data from clinical trials and protection of human subjects is the role of […]
2017 CDRH regulatory science priorities
The Center for Devices and Radiological Health (CDRH) recently issued its fiscal 2017 regulatory science priorities. The list repeats some of the points highlighted in its 2016 list, while surfacing some new issues for consideration. The CDRH started public disclosing it regulatory science priority list in FY 2015 and provides insight on how the agency […]
Compliance with ISO 14155:2011
IMARC Research has created a new whitepaper that highlights the Guidance for Ensuring your Clinical Study is Being Designed, Executed, and Monitored in Accordance with the ISO 14155.2011 International Device Standards. The goal of this paper is to introduce some suggestions on how to set up a study for successful compliance with both the FDA […]
Subject participation in clinical trials is paramount
Obtaining useful and meaningful data is one of the goals of any clinical trial. However, in order to attain the necessary data, subject participation in clinical trials is paramount as subjects are the heart and soul of a clinical trial. One of the keys to a successful clinical trial, no matter the stage or trial […]
Why conduct clinical vendor audits?
In today’s business environment, it’s important to have reliable partners who can help you achieve your business goals and objectives. In clinical research, this is especially true. One proactive way to ensure your trial partners are meeting your standards is to conduct vendor audits. Clinical vendor audits assess the performance of the multi-faceted service delivery […]
Comparing drug and medical device clinical trials
Understanding the similarities and appreciating the differences of drug and medical device clinical trials is important. A well-organized, controlled clinical trial can save time and money. Additionally, the faster and more accurately a trial is performed, the faster the test article can be introduced to the market and begin helping the community. Read on to […]