Data Management and Statistics

PSI uses Clintrial4™ as its data management system. In addition to offering complete data management services, PSI routinely provides the following services:

• Case report form (CRF) design
• CRF printing
• CRF distribution
• CRF management (retrieval and tracking)
• Fax/electronic CRF transmission
• Data validation
• Query resolution and tracking
• Retrieval, digitization and transmission of radiology images
• IVRS assistance (click on the crosslink for details)
• Maintenance of customized tracking databases
• Customized status reports
• Web access to enrollment and data-flow information, searchable tracking databases, and individual CRF images
• Double-key data entry
• Statistical analysis
• Report writing

Statistics

PSI statisticians can work with you to design your study, determine study endpoints, provide statistical methods and sample size determinations and provide quality data oversight throughout the program.

Meet the professionals at PSI: The Director of Statistics at PSI has 18 years of experience in the pharma industry, eight with PSI. Our statisticians and SAS Programmers have an average of 6+ years in the industry. Their level and depth of knowledge allow PSI to deliver on-time quality results to our clients.

The PSI Biometrics group has ‘hand’s on’ experience with Placebo–controlled Phase II-IV trials, Observational studies, Non-interventional studies/scientific programs and full integrated analyses of programs. The most recent therapeutic experience includes various oncology, respiratory and infectious disease indications, as well as analysis of data from programs of studies in Growth Hormone Deficiency, Osteoporosis, Hip Fractures, Diabetic Neuropathy, ADHD, Major Depressive Disorder, Erectile Dysfunction, Alzheimer’s and Bilateral Radical Prostatectomy.

In the past 5 years, PSI statisticians have analyzed data from over 30,000 patients. Our stats group has diverse experience in generating Statistical Analysis Plans, Final /Interim Analyses Reports, ISS/ISE Summaries, Annual Reports and Safety Reviews for DSMBs. They also support the compilation of Clinical Trial Reports and Manuscripts.

General PSI Statistical Services:

• Consultancy
• Protocol Development
• Randomization
• Review of IVRS specifications
• Development of Statistical Analysis Plans
• Review of Statistical Analysis Plans
• Final/Interim Analysis
• Safety review support (DSMB)
• Manuscript support
• Annual Report support
• CTR support (AE, ADS and Summaries)
• ISS/ISE preparation and review support

PSI Quality Systems & Support

• The SAS System
• nQuery Advisor
• Support for E-Submissions
  • Standard Data Tabulation Module ( STDM)
  • Analysis Data Module ( ADaM)
• Analysis Data Sets ( ADS)
  • Development of CDISC ADaM Structure of ADS
  • ADaM Specifications
  • ADS programming based on ADaM specifications
  • ADS transfers in xport format
• PSI Data Management & Statistics can provide development for CDISC, STDM and ADaM using EDC Data