We are excited to have recently launched IMARC University, our latest service offering designed to make clinical research education more widely available to the industry.  IMARC University is a series of affordable online training and continuing education courses designed to prepare you and your team for clinical research compliance.  These courses cover many aspects of the clinical research process, from FDA regulations and Good Clinical Practice standards to adverse event reporting and how to conduct monitoring activities.  All courses can be taken at your own pace.  We can even create and customize additional training to meet the needs of your team.

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.

As we continue to blog about the events that comprise our History of Clinical Research: A Timeline, we focus this month on the infamous Tuskegee Syphilis Study.

It should come as no surprise that FDA has released a new draft guidance regarding informed consent.  Every year, FDAs Bioresearch Monitoring Program (BIMO) releases summative information on the results of the inspections they have conducted on their website.  The results of the inspections conducted are a yearly focus of IMARC as we try to make sense of what the FDA is most concerned with regarding the conduct of research involving human subjects.  Almost inevitably, the most frequent citation from an FDA inspection at a clinical investigation site pertains to improper or inadequate informed consent.  Given that informed consent is one of the most important parts of the research process, it makes sense in that FDA is sharing yet again their “current views” on the concept.

Recently, we have noticed an increase in the demand for training across the clinical research landscape.  This should come as no surprise with the constant advances in technology improving the way that clinical research studies are conducted.  Those of us involved in this privilege are continually striving to keep up, and continuing education is a regular part our profession.  In addition, FDA regulations require that individuals involved in the clinical research process be qualified by training and experience.  But what constitutes “adequate” training?  This a question often asked of us by the sponsors and investigators we work with.

On June 2nd, FDA announced the launch of openFDA, a new program through their Office of Informatics and Technology Innovation (OITI).  The program is the latest step in FDAs commitment to increase transparency, and makes health data sets collected by the agency available to the public.  Currently, openFDA is in beta testing mode.  A definitive timeframe for when it will be released in full is not indicated.  The press release posted to the FDA website indicates that the initiative has first made accessible the adverse drug reaction report dataset.  This application programming interface (API) is “search-based” and consists of over 3 million adverse drug reaction reports accumulated from 2004 to 2013.  Future APIs currently listed as “coming soon” through the program include “Product Labels” and “Recalls.” 

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 calendar year.

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 calendar year.

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 calendar year.

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 calendar year.