IntegReview IRB Newsletter 

Volume 6 - Issue 1January 2014
In This Issue
IntegReview's Anniversary
Interoffice Announcements
Community Involvement
FDA Inspection
Industry Article
Site Training
Customer Affirmations
Upcoming Events

IntegReview is delighted to celebrate our 15 year anniversary on

January 26, 2014! 

 

Individual commitment to a group effort - that is what makes a team work, a company work, a society work, a civilization work.

-Vince Lombardi

 

Thank you for your continued trust & business that helps makes us successful.  Please meet and welcome our newest professionals:

 

Tony Dominguez, IRB Administrative Associate

Torey Turner, IRB Administrative Associate

Brady Mayfield, IRB Administrative Associate

 Zachary Heine, QC Associate

Schuyler Nelson-Brown, IRB Administrative Associate

Bridget Briseno, Office Assistant   

   
IntegReview Interoffice Announcements

 

5 YEAR ANNIVERSARIES 

  
October 6 - Rosa Sandoval, IRB Coordinator/Co-chair
  
October 6 - Fe Sandoval, QC Associate

 

10+ YEAR ANNIVERSARIES
  
October 2 - Terry Meyer, Vice President of Accounts (10)

 

October 22 - Melanie Flores, Director of Compliance (12)
  
November 12 - Lou Ashcraft, IRB Administrative Associate I (12)
  
Community
Involvement
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IntegReview is proud to support community organizations either through donations, corporate sponsorship, fundraising efforts and/or raising awareness by "walking for the cause".

 

 

 

 

 

 

Associations/Memberships

 

CIRB logo

 

 

 

BBB logo

 

Quick Links...

 

 
It is our commitment to provide exemplary protection to subjects while overseeing your research project.  Customers who entrust their business to us share a common desire to protect research subjects.  We pledge to do everything possible to earn the respect and trust of our customers while delivering a service that exceeds customer expectations.

Your interest and satisfaction is important to us.  If there is information/content you would like to see in upcoming issues please let us know by emailing [email protected]. 

   
Federal Agency Inspection
FDA blocks image IntegReview's most recent inspection performed by The U.S. Food and Drug Administration (FDA) that occurred in May 2013, resulted in no deficiencies, no inspectional observations and no Form 483 was issued.
   
Using Central IRBs for Multicenter Clinical Trials in the United States

 

Research institutions differ in their willingness to defer to a single, central IRB for multicenter clinical trials, despite statements from the FDA, OHRP, and NIH in support of using central IRBs to improve the efficiency of conducting trials. The Clinical Trials Transformation Initiative (CTTI) supported this project to solicit current perceptions of barriers to the use of central IRBs and to formulate potential solutions. They held discussions with IRB experts, interviewed representatives of research institutions, and held an expert meeting with diverse stakeholder groups and thought leaders. They found that many perceived barriers relate to conflating responsibilities of the institution with the ethical review responsibilities of the IRB. They identified the need for concrete tools to help research institutions separate institutional responsibilities from ethical responsibilities required of the IRB. One such tool is a document they created that delineates these responsibilities and how they might be assigned to each entity, or, in some cases, both entities. This tool and project recommendations will be broadly disseminated to facilitate the use of central IRBs in multicenter trials. The ultimate goal is to increase the nation's capacity to efficiently conduct the large number of high-quality trials.
  
  
Free Training?
Take advantage of nine free basic courses for investigative sites that IntegReview offers by registering on the Training Campus located on IntegReview's website.
 

Free Courses Include:

  1. The History of Clinical Research
  2. Participant Recruitment for Beginners
  3. Advanced Participant Recruitment
  4. Clinical Research Site Study Close Out
  5. Investigator Responsibilities in Clinical Research
  6. Regulatory Document Submission
  7. Ethics in Clinical Research
  8. Site Selection and Initiation Procedures
  9. Building a Successful Clinical Research Site

  

What Our Customers Are Saying...
"Multiple meeting dates, quick turn-around while still maintaining high quality standard."
  
"Good service, good QC, regulatory guidance." 
  
"Thank you for your business and for your staff, they are all great!  I receive great service from everyone I talk to."
  
Upcoming Events in 2014
February 4-6:  SCOPE Summit; Miami, FL (Exhibitor)

 

February 22:  IntegReview Human Research Protection Training Seminar; Austin, TX

 

April 26-29:  ACRP; San Antonio, TX (Exhibitor)  
  
May 4-7:  MAGI East Clinical Research Conference; Philadelphia, PA
  
June 15-19:  DIA; San Diego, CA  (Exhibitor)
  
October 10-12:  Site Solutions Summit; Amelia Island, FL (Exhibitor)

 

You can count on IntegReview to provide the highest quality IRB services.  We welcome the opportunity to assist you with your future research projects and look forward to a continuing relationship.
austin skyline IntegReview Ethical Review Board
3001 S. Lamar Blvd., Suite 210
Austin, Texas  78704
512.326.3001     512.697.0085 (fax)
  
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