Data Management & others services

  • eCRF analysis and design
  • Clinical database design and management (Oracle, MySQL, Postgres, SQLite, MS SQL) 
  • Database programming for cleaning procedures and clinical queries
  • Edit check analysis and design for eCRF data quality
  • Validation and Analysis Plan
  • Web-Based Randomization services (standalone or integrated with eCRF; sms/email/fax notifications)
  • Drug supply and resupply management system
  • Drug stock alerts (sms/email/fax) integrated with the Randomization services
  • Data collection and double data entry for paper crf
  • Database validation according to FDA and EMEA requirements
  • Advanced coding with dictionaries (e.g. MedDRA)
  • Database export in CDISC format
  • Database export for statistical analysis (SAS, SPSS, etc.)
  • eCRF and database export on durable media (CD for centers, sponsor, etc.)