QUALITY ASSURANCE Quality Management services from PSI increase your chances for obtaining quality data and a positive outcome of the audit by regulatory agencies. PSI takes a personal, interactive and global approach to quality management. Quality management provides quality systems which in turn guarantee good quality data in each clinical trial. Like other clinical trials services, PSI provides a dedicated Quality Management department staffed with qualiﬁed professionals. Quality systems implemented at PSI and managed by Quality Management ensure the quality, integrity, and accuracy of data for each clinical study undertaken at PSI. Our QM team members take pride in the positive outcomes for the audits by FDA/EMA that PSI-managed sites have undergone. Over recent years PSI has achieved no serious ﬁndings from the agencies for over 60+ FDA/EMA audits across multiple indications/locations and program complexities. In addition to the FDA /EMA audits, we have also had positive outcome of numerous audits by local authorities world-wide with successful results. Quality management from PSI drives acceptance. PSI takes a global approach to quality management by recognizing the need for global compliance to any given program. PSI quality management staff is knowledgeable in local, national, and international regulations and guidelines; our quality assurance auditors are multi-lingual and each have a depth of knowledge in GCP Guidelines and experience of conducting QA audits. PSI Quality Management team members take a personal approach to the process and interact with project management and other PSI divisions, across the globe, as well as with PSI vendors, to identity, correct or prevent challenges to a study. The PSI QM department is the owner of the following processes: Management of the PSI Quality Systems Documents (QSDs) Conduct and reporting of QA audits Vendor qualiﬁcation Conduct and reporting of mock regulatory onsite inspections ....continued
Investigator training in hosting and management of inspections by the regulatory agencies Hosting of regulatory authorities inspections of PSI and PSI-managed trial sites, including local sponsor representation CAPA investigations Information Security The PSI Quality Management department’s overall approach is one of collaboration and knowledge that creates an environment that leads to successful and positive outcomes.
WWW.PSI-CRO.COM PSI CRO AG Corporate Headquarters Baarerstrasse 113a, 6300 Zug, Switzerland • Tel: +41 41 228 10 00
Global Ofﬁce Locations North America: Ft. Washington, PA / Burlingame, CA / San Francisco, CA Latin America: Buenos Aires, Argentina Europe: Oxford, UK / Munich, Germany / Neusiedl am See, Austria Minsk, Belarus / Soﬁa, Bulgaria / Prague, Czech Republic / Tallinn, Estonia Budapest, Hungary / Milan, Italy / Warsaw, Poland / Bucharest, Romania Belgrade, Serbia / Kiev, Ukraine / Russian Federation: St. Petersburg, Moscow, Novosibirsk
Operational Presence by Region North America / Europe / Latin America Asia-Paciﬁc / South Africa