Centralized operational support and clinical trial expertise

US Oncology Cancer Research Services dedicates a central staff to provide support for physician practices resulting in efficient and strong local research programs. These activities range from study development support, regulatory support to comply with GCP and FDA requirements, and operational support.

Clinical research experience

• Over 14 years of experience conducting oncology trials
• Complete Phase I-IV capabilities
• More than 75 locations staffed for research
• More than 200 full-time employees dedicated to research
• Currently, more than 65 open trials under way for leading pharmaceutical and biotechnology companies
• 32,000 patients entered into trials since inception

Centralized operation support

Development

• Acquisition and development of new studies/molecules
• Protocol writing
• Scientific expertise in trial design
• Physician Review Committees
• Finance and contracts

Local operations support

• Study initiation and education
• Project and data management
• Training of local research staff
• Web-based Clinical Trials Information System
• Quality assurance
• Investigational pharmacy and drug management
• Research newsletter and communications
• Research publications

FDA Audit Experience

• 16 NDA FDA audits and 4 IRB FDA audits over the past five years
• Focused gene therapy audit, completed June 2000
• European Medical Evaluation Agency audit December 2000

Regulatory support

• Central Institutional Review Board
• Centralized safety reporting, tracking, and distribution
• Centralized database for site activation and regulatory approval
• FDA audit support