Whether your project is a specific regulatory submission, a complement to your clinical trial management or a full service program, CE3 generates a seamless solution at the highest level by integrating collaboration, experience, efficiency and excellence in every deliverable. CE3 's extensive experience and attention to detail have led to successes in a comprehensive range of services from early stage clinical development to regulatory submissions. Our core offerings through all stages of developments include:

Clinical Study and Site Management

• • Trial Feasibility Evaluation
• • Global Project Management
• • Site Selection and Qualification
• • Study Management
• • Site Management
• • IRB and Ethics Submissions
• • Site Monitoring and Training
• • Contract and Budget Negotiations
• • Vendor Management

Medical/Regulatory Writing

• • Development Plans
• • Safety Review Charters
• • Protocol writing
• • Clinical Summary Reports
• • Safety Narratives
• • IND's
• • NDA's
• • CTD's
• • PIP's
• • Position Papers

GCP Auditing

• • Investigational Site Auditing
• • Vendor Auditing
• • Audit Preparation

Statistics and Data Management

• • Data Management
• • Database Programming
• • Sample Size Estimations
• • SAP Creation
• • Statistical Programming
• • CDISC STDM and AdAM formatting
• • EDC or Paper CRF development
• • Standards Development