CRO Industry Pulse
Criterium, Inc. Client
(Rayner Intraocular) Receives FDA Approval
Rayner Intraocular Lenses Ltd. Announces Approval of C-flex™
Injectable
Intraocular Lens.
(June
14, 2007 – Saratoga Springs, NY) Rayner Intraocular
Lenses Ltd. of Great Britain has proudly announced that
it is the first Intraocular Lens manufacturer based
outside the United States to receive FDA PMA approval
for an IOL product in over 20 years. Their C-flex™
injectable acrylic lenses had already been approved
and in use in Europe and throughout the rest of the
world.
Criterium, Inc. provided Project Management,
Data Management and Statistical support for Rayner’s
clinical trials on this device leading to FDA approval.
"The clinical trial was well
organized and executed. Criterium and their people formed
a capable, competent and efficient partner in this process,”
commented Mark Mullaney, Regulatory Affairs & Quality
Assurance Director for Rayner “Any queries from
the investigational sites, the monitors and/or the FDA
were responded quickly and to everybody's satisfaction."
In this clinical study Criterium
remotely managed sites in the United States, Austria
and Germany. Using real-time processes, Criterium standardized
the data management across national borders for multiple
studies, and supported multiple submissions and supplements
to the FDA until its eventual approval within months
of the final 3 year evaluation.
The Centerflex™/ C-flex™
study program was initiated with the first patient enrolled
in December 2000 and a total of 483 patients were enrolled
through the end of 2004. Over the course of each study,
data was managed through Criterium’s proprietary
trial management software (StudyControl ™), where
real-time data gathering and analysis processes provides
continuous information, metrics and reports about site
performance.
“We are extremely pleased that
the technology applications we developed for these studies
on behalf of Rayner had such a positive response from
the FDA,” said John M. Hudak, President and Founder
of Criterium, Inc. “Criterium enhanced these tools
over the course of the study while staying true to our
goal to deliver every project, to every client, done
correctly and on time. The real-time capabilities of
our processes were essential: Criterium’s remote
site management and daily review of data led to a reduced
number of monitor visits to sites, because each visit
was more productive. The most important outcome is regulatory
approval
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