PMI Performance 2008
Costa Mesa, California – February 2, 2009 - During
the past exceptionally busy and productive year, PMI experienced
a number of significant accomplishments and made key investments
that will benefit our clients in 2009. Please read below to
learn more.
CONTINUED QUALITY PERFORMANCE
1. PMI's project teams completed site management, monitoring
and data management activities in support of PMA submissions
for four Class III medical device studies, while receiving
no 483 observations associated with our services.
2. We successfully completed our ISO 9001:2000 certification
renewal audit, and continue to be one of a few CROs with this
credential.
3. We continued to receive high satisfaction scores from
our sites and sponsors, which validates our commitment to
provides efficient, high-quality professional clinical trial
management services.
INCREASED STAFFING/EXPANDED THERAPEUTIC AREAS
1. PMI increased project capacity and resource depth via
investments in additional clinical operations and support
staff during 2008. By increasing the number of project managers,
clinical research associates (MDs and RNs), data management
and statistician employees, as well as Quality System and
IT support staff, PMI is optimally positioned to implement
an expanded project mix.
2. As many of our clients and friends know, PMI has a long
track record with clinical trials of medical devices and ophthalmic
products. Our new staff brings additional relevant experience
in aesthetics, cardiovascular therapies, gastroenterology,
metabolic disorders, in vitro diagnostics (IVD), oncology,
CNS, and vaccine therapies.
EXPANDED SERVICE CAPABILITIES
PMI expanded its network of consultant alliances in related
areas to facilitate client programs from product development
planning through product launch.
INCREASED STUDY SITE AND INVESTIGATOR RESOURCES
Entries in our investigative site database grew significantly,
which further increases our access to experienced sites and
investigators across a broad array of therapeutic areas. In
addition to basic information about potential study sites,
PMI's database maintains performance metrics to facilitate
objectivity in assessing candidate sites.
We are excited about our recent accomplishments and confident
they will lead to greater efficiencies and continued high
quality services for our clients. Our project and data management
teams have the depth of experience to facilitate expanded
studies and our affiliations with investigators and study
sites give our clients a broad base of expertise from which
to draw on for their clinical trials. We look forward to working
with you in the coming year!
To learn more about our capabilities or services, please
call us at 714-460-7363 or visit Promedica International on
the web.
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