Services

By: Ce3 Inc  09-12-2011
Keywords: Project Management, Clinical Development

Ce3

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

Keywords: Clinical Development, Project Management

Other products and services from Ce3 Inc

09-12-2011

Service

CRAs communicate regularly with Investigators and investigative sites to verify patient enrollment, review study progress, answer protocol questions, discuss CRF completion and ensure the study is moving forward on time and as planned. The complexities of drug development and clinical study activities require constant monitoring of numerous key variables to assure adherence to project timeliness and provision of high quality data.