Clinical Data Management and Biostatistical Services

Our clinical data management services include:

  • Rapidly deployed electronic data capture (EDC) system in support of Phase I studies conducted in our Frontage clinics using Medrio
  • Stand alone and integrated data management services for early phase multicenter trials conducted at external investigative sites using Medrio, Oracle Clinical RDC and Medidata RAVE
  • Database and eCRF design
  • Clinic staff training
  • Data management and validation plans
  • Edit and validation checks
  • MedDRA and WHO drug coding
  • Data listings generation

Our biostatistical services include:

  • Sample size calculations and study design consultation
  • Statistical analysis plans
  • Validated SAS programming for Tables, Listings, Figures
  • Interim analyses
  • Statistical analyses in support of BE, PK/PD analyses
  • Efficacy and safety analyses