IntegReview Ethical Review Board

IRB Newsletter 

Volume 2 - Issue 2

May 2010

 

 

 

What are Some Challenges that IRBs are Facing?  

 

Lynn Meyer, IntegReview President, was one of four IRB representatives included in an article published in the April issue of PharmaVOICE.  

 

Article written by Taren Grom, READ HERE.

 

 

 

IRB QUALITY

 

The trending results for

Q1 2010 represent an average of 99.10% accuracy rate.

 

IntegReview maintains a CAPA program that tracks the quality of study documents and determines when/where to incorporate corrective action as to not repeat an error.  Our CAPA program encompasses errors found internally prior to leaving our office as well as those errors discovered by our clients.

 

 

 

 

IntegReview is a proud supporter of SafePlace, a non-profit organization that exists to end sexual and domestic violence through safety, healing and prevention for individuals, families and our community.  April was Sexual Assault Awareness & Prevention Month.  By participating in Demin Day, IntegReview made a difference by wearing denim to show their support of survivors of sexual assault and stating there is never an excuse for rape. 

 

 

 

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Happy Spring!

 

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.

 

 

 

                    

The FDA released a draft guidance February 25th for pharmaceutical and biologics developers on adaptive design clinical trials.  The 50-page guidance covers the clinical, statistical and regulatory aspects of adaptive design clinical studies, and focuses on adaptive designs that are not well-understood.

 

"Protecting study blinding is particularly important to avoid the introduction of bias in the study conduct and to maintain confidence in the validity of the study's result," the guidance said.  CLICK HERE to access this guidance document and learn more.

 

 

 

FDA Draft Guidance on Non-inferiority Trials

                

The FDA released a draft guidance on conducting non-inferiority clinical trials on February 26th.  The 60-page guidance discusses the regulatory, study design, scientific and statistical issues facing non-inferiority studies used to establish the effectiveness of a new drug. 

The guidance noted that there is increasing interest in comparative effectiveness studies. "Where comparative effectiveness is the principal interest, it is usually important - where it is ethical ... - to include a placebo control as well as the active control. ... Inclusion of a placebo group can provide clear evidence that the study did have assay sensitivity (the ability to distinguish effective from ineffective treatments), critical if a finding of no difference between treatments is to be interpretable."  CLICK HERE to access this guidance document and learn more. 

 

 

 

What Our Customers Are Saying...

 

"If you are looking for an IRB that provides quality review of submissions, quick turn-around-time and excellent customer service, then look no further. IntegReview offers all of the above with a professional staff that is more than willing to help make the submission process as easy and painless as possible."

 

"IntegReview provides prompt service, properly conformed documents and knowledgeable staff to answer questions in unusual situations."

 

"You can always get someone on the phone when you call; ease of completion of reports."

 

 

 

Upcoming Exhibiting Events in 2010

June 13-17:  Drug Information Association (DIA), Washington, DC - Booth #317 
October 15-17:  Site Solutions Summit (SSS), Clearwater Beach, FL  

 

 

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, TX  78704

 

 

 

 

 

 

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IntegReview | 3001 S. Lamar Blvd. | Suite 210 | Austin | TX | 78704