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.