
Clinical Operations Services
With over 40 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