CRI Worldwide

Clinical Development Program Design

• Clinical Development Program Design
• Protocol Design and Development
• Public Source Meta-Databases for Modeling
• Treatment Optimization
• Computer Assisted Trial Design (CATD) and Analysis
• Modeling and Simulation for Competitive Product Positioning
• PK/PD Modeling and Analysis
• Population PK Modeling and Analysis
• Bridging Strategies
• Decision Support for In-Licensing
• Modeling and Simulation Training
• Reporting and Analysis Services

Project Management

• Senior Project Managers
• Years of Clinical Trial Experience
• Single Point of Contact throughout Research Program
• Direct Access to all Clinical and Scientific Staff as Desired
• High Sense of Urgency and Bias for Action

Clinical Trial Management (CTM)

• Inpatient and Outpatient CTM Services
• Premier Phase I/Early Stage Capabilities
  • ADME
  • Bioequivalence / Bioavailability
  • Cardiac Safety & QTc
  • Dose Ranging & Maximum Tolerability
  • Drug Interaction & Drug Metabolism
  • Food Interaction
  • EEG / ECG
  • Mechanism of Action
  • MRI
  • PET Scanning
  • Pharmacokinetics (PK)
  • Pharmacodynamics (PD)
  • Radio-labeling
  • Safety & Efficacy Testing
  • Smoking Control
  • Structure-activity Relationships
  • Surrogate Marker
• Phase I-IV Therapeutic Expertise
  • Central Nervous System (CNS)
  • Cognition/Psychiatry
  • Pain/Analgesia
  • Sleep
  • Alzheimer's
  • Cardiovascular
  • GI
  • Immunology
  • Oncology
  • Respiratory
• Multi-center Trials
• Capacity and Access to Over 150 Total Beds
• Over 100 Fully Licensed Hospital Beds
• 34 Bed Hospital-Based Inpatient Unit with Code Team
• Fulltime Clinical Staff (Doctors, PhDs, Nurses, CRCs, Lab Technicians)
• Independent Quality Function

Patient Recruiting Services

• Extensive Patient Database with more than 40,000 Listings
• Call Center
  • Fully Staffed, Trained and Dedicated Team
  • Nearly 90% Live Answer Rate
  • Evening and Weekend Coverage
  • Dramatically Improved Advertising ROI
  • Leading Enrollment Rates
• Transportation Services
  • Full-time Fleet of Passenger Vans
  • Professional Drivers and Dispatch
  • Appointment Validation Process
  • Specialize in Patient Care and “Handholding”
  • Dramatically Improves Show Rate
  • Dramatically Improves Outpatient Retention
• Community Outreach Programs and Staff
• Centralized Patient Assessment Center

Clinical Monitoring

• Site Qualification Visits
• Initiation Visits
• Periodic Monitoring
• Study Close-outs
• Training of CRAs and/or Study Coordinators

Data Management

Clinical Data Management Services

• Case Report Form Graphic Design
• Database Development/Validation
• Data Entry/Verification
• Electronic Data Importation
• Web-based Data Capture
• Clinical and Diagnostic Data

Review and Query Generation

• Query Application and Database Correction with Full Audit Trail
• Coding of Adverse Events (Proficient with MedDRA, Costart, NCI, WHOART)
• Coding of Medical History
• Coding of Medications
• Dataset Creation/File Transfer (SAS datasets, SAS Transport Files, ASCII files)

Reporting and Analysis Services

• SAS Application Programming: Tables and Listings
• Standard Safety Report Development
• CDISC Reporting
• SAS Transport File Development and Validation
• Integrated Summary of Safety
• Integrated Summary of Efficacy
• Complete Biostatistical Services from Analysis Plan to Statistical Report

Data Validation and Auditing Services

• Database Quality Control Audits
• Program Validation
• Review of Data Listings and Tables
• Investigator Site Audits
• Clinical Study File Audits
• Clinical Study Report Review
• SOP Development
• Process Mapping