Phase IV Clinical Trials

INC Research/inVentiv Health's Late Stage leaders help world class companies bridge the gap from development to commercialization. The key is recognizing that Phase IIIb/IV researchis conducted for different reasons than pre-approval studies. Post-approval success is achieved through documentation and persuasive demonstration of safety and value - and through an operational approach that reflects the unique characteristics of Late Stage studies: different goals, different measures, different stakeholders, and different timeframes.

At INC Research/inVentiv Health, we strive to ensure our clients' Late Stage initiatives achieve both strategic and scientific objectives by leveraging our unique perspectives and global resources. With expertise in Observational (non-interventional) Research and Patient Registries,Interventional IIIb/IV studies and Endpoint programs, Health Economics and Outcomes Research, and Risk Management and Epidemiology, our Late Stage team capabilities span the full spectrum of needs.

We have unique perspective and insight into the organizational dynamics that can make or break a Late Stage initiative, and are regularly called on to provide leadership, vision, and training. This added dimension has enabled our clients to achieve consensus and clarity and highly effective Late Stage initiatives - that often commence well before product approval.

Our goal is to help our clients achieve both commercial and scientific success through a balanced and operationally cost-efficient approach that recognizes the unique attributes of the post-approval landscape.

Our services are designed to document and demonstrate "real world" safety and value.

CLINICAL PERFORMANCE

• Observational (Non-interventional) Research and Patient Registries
• Interventional IIIb/IV Studies
• Comparative Effectiveness Research
• Retrospective Data Analyses
• Expanded Access and Compassionate Use Programs
• Label Extensions
• Endpoint Studies

HEALTH ECONOMICS AND OUTCOME RESEARCH

• Cost-effectiveness Studies
• Economic Analyses and Models
• Global Value Dossiers
• Patient-Reported Outcomes Research
• Direct-to-patient Disease Registries
• Pricing and Market Access

RISK MANAGEMENT AND EPIDEMIOLOGY

• Post-approval Safety Surveillance
• REMS/RMPs - Consulting and Implementation
• Signal Detection
• Meta-Analysis