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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. |
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.
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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.
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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FDA released a draft guidance February 25th for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Draft Guidance on Non-inferiority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FDA released a draft guidance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 |
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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. |
IntegReview Ethical
Review Board
3001 S. Lamar Blvd., Suite
210
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