Data Management & Biostatistics

psn ‘s main goal is to deliver quality databases on time and within budget. We understand that data analysis is a critical component to each study and its procedures and systems are compliant with ICH and GCP Guidelines, including FDA 21 CFR Part 11.

psn offers the following Data Management services adapted to sponsor’s requirements:

• CRF design, review, printing and distribution
• Generation of randomization list and coded envelopes (IVRS/IWRS)
• Data management plan writing
• Database design, testing and maintenance
• Data entry (manual double or OCR-TELEform)
• Upload of external data (e.g. laboratory, ECG, MRI, etc.)
• Data validation plan writing
• Consistency/plausibility checks programming
• Data cleaning (including Data Queries management and DB Editing)
• SAE Reconciliation (including management of discrepancies)
• Data Management Report writing
• Database transfer to Sponsor (SAS, SPSS, Oracle Clinical, Access, SQL)
• Data coding (MedDRA, WHO Drug Dictionary, ATC, etc)

Specific services related to Remote Data Capture / eCRF:

• eCRF design
• Project website preparation
• Study database setup
• Set-up of check controls
• Set-up of the e-queries management
• Set-up of On-line Automated reports
• Definition, preparation and management of the users profiles/passwords
• Technical system maintenance
• Help-desk
• Link with external database
• Transfer of CRFs to Study sites

psn offers the following Statistics services (SAS, SPSS):

• Biostatistical consultancy on design and methodology
• Development of statistical section for trial protocols
• Adaptive design planning
• Sample size calculation
• Interim analyses
• Statistical reports
• Public health benefits studies
• Biostatistical evaluations
• Integrated statistical/clinical report