Overview

The key to PharmaVigilant's success and client satisfaction is a comprehensive study design process that adheres to all regulatory guidance's. Our study design process is the fastest and most streamlined in the industry, and our project managers are all Lean Six Sigma qualified Green/Black Belts. This ensures that they are designing your study with the highest level of efficiency. Our study design process enables us to normally deploy in 4 weeks after receiving final protocols CRF design, including User Acceptance Testing (UAT).

Study Design Approach:
 

• Randomization Algorithms
• Form Design (utilization of extensive Form libraries)
• Edit Check Design (utilization of extensive Edit Check libraries)
• Flow Control Design
• Imports - Labs, central and local/ ePRO
• Data Warehouse Design - inclusion of completed studies
• Inclusion of other on-going studies in the program regardless of whether they are being conducted in other platforms (paper, other EDC), or with other vendors (other EDC companies). All data can be loaded and analyzed
• Reports - Standard or custom reports defined
• InSpire Reporting Tool - Design of standard adhoc reports to be included for end users
• Exports - Standard exports  (Ascii, SAS, CDISC ODM) or custom (CDISC SDTM)
• Unlimited Rights and Roles within the system - extensively used to get the right information to the right individuals
• Auto coding - Define dictionaries to be used
• CTMS Defined - Enrollment, CTMS algorithms defined
• Training - Method and training database defined
• I-Vault  electronic Trial Master File definitions
• Study Close
  • PDF for sites and sponsor
  • Exports - Final
    • Source Documents
    • Clinical Data
    • Images
    • TMF/Regulatory