Late stage (Phase IIIb-IV) clinical research is undertaken for different reasons than pre-approval studies. Post-approval success relies on documentation and persuasive communication of safety and value, as well as an operational approach that reflects the unique characteristics of late phase studies – their goals, measures, stakeholders and time frames.
Leveraging Our Unique Perspectives and Global Resources to Achieve Your Late Stage Objectives
The breadth of our experience and services provides us with unique insights into the organizational dynamics that influence a late stage initiative. This provides our customers with consensus and clarity, leading to highly effective research programs that often commence well before product approval. Our customers benefit from achieving both commercial and scientific success through a balanced and operationally cost-efficient approach that recognizes the distinct attributes of the post-approval landscape.
Covering the Spectrum of Safety and Value in Late Phase
Our clinical services include observational (non-interventional) studies and patient registries; comparative effectiveness research; interventional studies; safety surveillance studies; risk management/epidemiology; endpoint studies; compassionate use programs; and label extension studies.
Our humanistic offering covers patient-reported outcomes research; quality-of-life instrument development and validation; quality-of-life studies; and direct-to-patient registries.
In terms of economic services, our Late Phase team has extensive experience in cost-effectiveness studies; economic models; global value dossier development; health technology submissions; meta and database analyses; and pricing and reimbursement support.
Observational Research and Patient Registries
All stakeholders want information to understand what works in the real world, beyond the constraints of clinical trials. Observational studies look at outcomes in everyday medical practice, and observational research presents both opportunities and limitations, requiring a firm strategic foundation to determine how it should be constructed.
We provide a wide range of services in order to meet your objectives, including study design (statistical analysis planning and communications planning); overall project management/management of scientific advisory panels; protocol/guidelines development (informed consent, case report forms); site recruitment and management (site agreements, EC/IRB approvals); data management (EDC, EMR, paper, hybrid); quality management (site interaction, data quality monitoring and SDV, safety reporting); and analysis and reporting (presentations, abstracts, manuscripts).
Emerging Trends in Observational Research
Our semi-annual Survey on Observational Research provides below-the-surface insights into the industry, revealing challenges and best practices, as well as contributing to improving understanding and consistency in this new and important category of research.
Respondents include industry professionals, regulatory agency personnel, providers and academics from more than forty countries.