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CDRH Sets Performance Goals

CDRH Sets Performance Goals

The FDA’s device center (CDRH) has established time based performance standards to help ensure draft guidance documents do not remain in an unresolved state for too long.  The following draft performance goals have been outlined:

38 Million Reasons to Improve Clinical Trials

38 Million Reasons to Improve Clinical Trials

On Friday, May 23, 2014 the Federal Register announced a notice that in an effort to increase the quality and efficiency of clinical trials, the Food and Drug Administration (FDA) was planning to grant a one-year, $7,500,000 grant to Duke University’s Translational Medicine Institute (DTMI) (renewable up to a total of five years, $37,500,000). This grant would primarily go to fund the public-private partnership Clinical Trials Transformation Initiative (CTTI).  CTTI  was originally created as a partnership between the FDA and Duke University in 2008, but now includes more than 60 organizations with representatives from government agencies, industry, patient advocacy groups, professional societies, investigator groups, academic institutions, and other interested parties.

FDA Guidance Documents: Definition and Database

FDA Guidance Documents   Definition and Database

What is a guidance document and how should they be used? A guidance document represents the FDA’s current thinking on a topic. Per FDA’s website, guidance documents “do not create or confer any rights for or on any person and do not operate to bind FDA or the public. You can use an alternate approach if the approach satisfies the requirements of the applicable statues and regulations.” Guidance documents usually discuss FDA’s interpretation of their policy on a regulatory issue.

The Guatemala Syphilis Experiment

The Guatemala Syphilis Experiment

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 year.

Trust the Process – A Case Study

Trust the Process - A Case Study

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.

GCP… What Does it Mean?

GCP… What Does it Mean

Do you know why rules, regulations and standards exist? What exactly is Good Clinical Practice and how does this help protect patients and data integrity?

Inspection Ready: Are you Ready for an Inspection Tomorrow?

Inspection Ready   Are you ready for an inspection tomorrow

Recently, a clinical site received a call from an inspector on a Thursday notifying the site of a not-for-cause inspection the following Monday. This was a short gap of time between the notification and actual audit conduct. How can sites make sure they are ready if an inspector calls today?

Does Effective Clinical Data Management Require a Monitor in the Field?

Does Effective Clinical Data Management Require a Monitor in the Field

What is the ultimate goal for every clinical trial?  High-Quality Data that proves safety and/or efficacy endpoints while safeguarding clinical trial participants. How can data integrity be ensured? This requires a combination of a few key players during the course of a study.

5 New Year Resolutions from a Monitor

5 New Year Resolutions from a Monitor

We’re often asked- What makes a good monitor? What’s involved in the day-to-day of being a CRA? Well, it’s no secret that a good monitor often wears and juggles many hats; from reporter, to auditor, to traveler. And like many with this New Year quickly unfolding there are some resolutions from those that live out the day-to-day of clinical research monitoring:

Helping to Inform and Educate

Inform and Educate

IMARC Research continues to focus on being an industry thought leader through our whitepapers, infographics, speaking engagement and blogs.  During 2014, IMARC Research continued this tradition by publishing content that help inform and education our industry.

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