Research Services

Clinical Trials Office Services

  • Phase I-IV
  • Multi-Site Coordination
  • IND/IDE Support
  • Trial Supply Chain Management
  • Budget and contract negotiation
  • Feasibility assessment
  • Consultation services
  • IVRS - phone and web based

Special Populations

  • Neonatal
  • Infant
  • Pediatric
  • Adolescent
  • Developmental Conditions
  • Young Adult
  • Obstetrics and Gynecology
  • Pre and Post-Menopausal Women
  • Geriatrics
  • Injury Specific Conditions

Protocol Designs

  • Adaptive design
  • Optimal Design
  • Cross-sectional and longitudinal
  • Discordant Phenotype Analysis
  • Experimental/quasi-experimental designs
  • Feasibility Studies
  • Pharmacometric (PK/PD/PG)
  • Randomized
  • Retrospective
  • Qualitative/Quantitative

Data Management

  • Case report forms (CRF) & eCRFdesign
  • Database design
  • Double-data entry and Quality Control
  • Query generation and processing
  • Electronic data integration & transfer
  • Serious AE reconciliation

Modeling and Simulation

  • Efficiency of Clinical Trial Design
  • Clinical Trial Simulation to Predict Outcomes
  • Development, Execution and Data Analysis

Monitoring and Auditing

  • Pre-study site qualification and evaluation
  • Site initiation, interim monitoring and closeout
  • Monitoring plans
  • Identifying and resolving adverse-event issues
  • Quality control and training programs

SERVICES

  • Special Populations
  • Multi-Site Coordination
  • Data Coordinating Center
  • Protocol Design
  • Phase I-IV Services
  • Recruitment & Retention
  • IND / IDE Services
  • Monitoring & Quality Assurance
  • Research Kit Production
  • PK /PD Modeling & Simulation
  • Data Analysis
  • Project Management

Upcoming Events

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