IMARC Research, Inc.

Category: Content
Type: Blog Article

Generated 2 days ago

New blog articles detected

  • Maintaining Professionalism During a Conflict

    Maintaining professionalism in a difficult situation is unfortunately something most professionals encounter during their career. Being able to keep calm and stay logical during these times is key to maintaining trust with a client, and helping them feel comfortable and confident to work with you to resolve the issue(s) at hand. For Clinical Research Associates (CRAs), diplomacy and ta...

IMARC Research, Inc.

Category: Content
Type: Blog Article

Generated 1 week ago

New blog articles detected

  • How a Federal Regulation is Born

    Regulations are a set of legal rules that are established by a regulatory authority such as the FDA. They are required to be followed and are enforceable by legal consequences such as fines or imprisonment. The process of making a regulation can be a lengthy but important process. Federal agency priorities, industry trends, public safety, or new technology are potential reasons for cre...

  • Are Clinical Vendor Audits Important?

    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.

IMARC Research, Inc.

Category: Content
Type: Blog Article

Generated 2 weeks ago

New blog articles detected

  • 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 patients.

  • 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 uniformity, understanding, and complianc...

IMARC Research, Inc.

Category: Content
Type: Blog Article

Generated 3 weeks ago

New blog articles detected

  • 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?

  • The ICH E6(R2) Addendum - An Intro to the What and Why of the Changes (Part 1)

    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 over the past twenty years; however, increas...

  • How to Prepare for an FDA Audit

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

  • Comparing Significant Risk vs. Non-Significant Risk Studies

    What is the difference between Significant Risk studies (SR) and Non-significant Risk studies (NSR)?

  • ALCOA – A Tool to Document Your Work

    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 w...

  • 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 every individual on the...

  • 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.

  • 10 Keys For Responding to an FDA Warning Letter or Form 483

    Each year, IMARC releases a whitepaper listing of the top reasons for FDA warning letters, here is the listing for 2015. Provided below are 10 Tips to consider when responding to a FDA Warning Letter or Form 483: 

  • 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 regulations and ISO 14155, giving some pract...

  • 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 type, whether it is a drug or device study, is meeting subject enrollment...

IMARC Research, Inc.

Category: Content
Type: Blog Article

Generated 5 months ago

New blog articles detected

  • Organization: The Master Key to Compliance

    While good organizational skills may present a challenge to many of us, allowing disorder to follow us to work is simply a recipe for disaster. Not only can disorganization create for a hectic day, it can also lead to larger problems with industry compliance standards and FDA approvals. Whether your company is involved in drug trials or device studies, poor organization can leave your ...

  • ALCOA - The Best Way to Document Your Work

    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 w...

IMARC Research, Inc.

Category: Content
Type: Blog Article

Generated 5 months ago

New blog articles detected

  • 5 Tips for Meeting the UDI Deadline

    The FDA’s Unique Identification program directs that class II device-makers to be compliant with the law by September 24, 2016. Based on this deadline, there is evidence that many manufacturers are unprepared for the next phase of the agency’s UDI rule.

IMARC Research, Inc.

Category: Content
Type: Blog Article

Generated 5 months ago

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