Clinical Operations Services


Clinical Operations Services


With over 35 years experience in clinical data management and clinical operations, we have a rich industry experience and a unique perspective as a result of having worked in pharmaceutical, biotechnology, contract research organizations and consulting.
 
Our previous hands-on experience includes:


  • Leading global SOP development and implementation while at several international companies
  • Development and project management for implementation of electronic data management systems while at several international companies
  • Worldwide implementation of a clinical data management system for a global biotechnology company
  • Development and implementation of an innovative outsourcing structure for a biotechnology company
  • Business development for several international CROs
  • Organizational development of clinical data management, clinical operations, biostatistics and IT departments at several start-up companies
  • Professional society leadership while serving on the Board of Trustees, and as Vice Chairman and then Chairman of the Board of the Society for Clinical Data Management
  • Budget and staffing modelling
  • Serving as an expert consultant on numerous National Institutes of Health (NIH) project review boards


Blue Ridge Consulting can assist you and your organization in:

  • Proposal Review
  • Protocol Review
  • CRF Design Review
  • Budgeting & Resource Planning
  • Project Management
  • International Standardization
  • Metrics Development
  • Organizational Development & Staffing
  • CRO Selection
  • CRO Management
  • Standard Operating Procedures:
  • Development & Implementation
  • Auditing


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