Strategic Consulting

GAP Analysis

• Evaluate current state of operations and recommend solutions for resourcing, processes, and technical infrastructure

• Develop efficient operational data flow model for Biometrics and adjacent functions

• Propose metrics and reporting

Implementation & Resourcing

• Advising on best practices for CRO / vendor oversight

• Recommend vendor partners who will set-up, implement and maintain solutions for customer

• Develop job descriptions and advise clients about in- and out-sourcing models - and which one may best fit

Digital Infrastructure

• Develop company-specific technical infrastructure plan

• Select effective systems and solutions (EDC, SAS, data visualization tools, eTMF, sFTP, clinical data repository, and beyond)

• Recommend infrastructure that will fit well within Clinical Development including private cloud, secure access, data lake, data flow and machine automation for remote access

Process Development

• Develop SOPs, Work Instructions, Templates and Guidelines in coordination with Quality Assurance

• Process mapping (initial work and then later for efficiency)