A flexible suite of clinical development services

Project Management

Risk and contingency planning
Clinical trial risk management
Clinical trial feasibility
Clinical trial site selection
Statistical modeling
Senior management project review
Quality control and oversight
Regulatory consulting and filing

Study Launch

Clinical trial feasibility
Clinical trial site selection
Project plans
Kick-off meeting

Study Documentation

Protocol design and review
Statistics consulting
CRF design

Site Centric Focus

Site profiling
Site activation
Site support
On-site/remote monitoring

Data Management and Analysis

EDC or paper data capture
Data integration
Statistical analysis and reporting
Clinical study report writing

Quality Assurance

GCP, GLP, and GMP audits
21 CFR Part 11 computer validation audits
Clinical study report audits
Database audits
Compose Standard Operating Procedures (SOPs)
Develop regulatory policy and strategy

Patient Safety

Medical support
Drug safety and reporting

Trial Support Services

Interactive Voice/Web Response (IVR/IWR) Services
Cardiac safety
Central laboratory
Vendor management