Data Management and Statistics

Data Management PSI Data Management is a key cornerstone to our clinical trial services and as such delivers high quality data due to the development of standardizations and processes implemented globally by PSI. Data is delivered in a rapid manner with validation and verification procedures that ensures quality assurance at every step of the process within PSI. From database creation to database lock, our PSI Clinical Data Management group provides and becomes an extension of your clinical team.

The PSI Data Management Team:

• Proactive solutions are the key to our Data Management professional’s success at PSI.
• Our centralized data management group has an average of 11+ year’s industry experience with < 5% department turnover
• Processes and global standards are in place enabling PSI to complete and deliver quality results for studies of varied size and complexity across all therapeutic areas
• 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
• Paper CRF printing and distribution
• Paper CRF tracking
• Double-key data entry (paper CRF)
• Clinical database design and set-up
  • 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)
  • EDT specification
  • Reconciliation of transferred data against CRF data
  • Integration of transferred data into clinical database
• Data validation
• Query generation & resolution
• Review of resolved queries in EDC systems
• SAE reconciliation
• Coding of medical terminology (adverse events, medical history, medications)
• MedDRA
• WHO Drug Dictionary
• Clinical database lock
• Clinical database transfers (interim, final)
• SAS datasets
• SAS XPORT transport files
• Maintenance of Web-accessed study-specific tracking systems (enrollment, CRF/query tracking)

Data Management Systems

• ClinTrial™ (Part 11 Compliant)
• The SAS System

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