CLINICAL DATA MANAGEMENT PSIs clinical trial Data Management group is at the core of our clinical trial services. Globally-implemented standardizations and processes guarantee consistent, high-quality data. Data is delivered rapidly, with quality assurance ensured by validation and verification procedures at every step of the process. PSI becomes an extension of your clinical team from database creation to database lock. PSI Clinical Trials Data Management Services: Proactive solutions are the key to PSI Data Management success Clinical trial data management processes and standards have been developed to enable PSI to deliver high quality results PSI data management can be utilized for clinical trials of various size and complexity, across a range of indications Centralized PSI data management group has <5% department turnover with an average of 12+ years of industry experience Sponsor focused teams Flexibility to deliver EDC or Paper globally with on-time quality results Electronic Data Capture (EDC) - PSI has worked with a variety of EDC platforms and vendors over the years. We have the ability and knowledge to provide our clients with the right EDC solution that meets their specific study needs. Global Standards & Services Development of paper CRF/eCRF Double-key data entry (paper CRF) Deliverable clinical database is developed using CDISC SDTM standard Data definitions are provided in accordance with CDISC CRT-DD specification UAT in EDC systems Management of electronically transferred data (Central labs, central readers, etc) Reconciliation of transferred data against CRF data
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Integration of transferred data into clinical database Data validation Query generation & resolution SAE reconciliation MedDRA WHO Drug Dictionary Clinical database transfers (interim, final) SAS datasets SAS XPORT transport files Data Management Systems ClinTrial™ (Part 11 Compliant) The SAS System
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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