Advertisement Data Management & Biostatistics - Pharmaceutical Business review

Advertisement

Pharmaceutical Business review is using cookies

ContinueLearn More
Close
More info about

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.

0

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
Quick Contact Data Management & Biostatistics