Phase IIIb-IV
Late Phase Clinical Trials Have Unique Needs, that require Unique Solutions
Post-approval success relies on documentation and assertive communication of safety and efficacy, 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.
Observational Research and Patient Registries
Observational studies focus on outcomes in everyday medical practice, and observational research presents both opportunities and limitations, requiring a firm strategic foundation to determine how it should be planned.
We provide a wide range of services 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.
People participating in this survey come from over forty countries, including industry professionals, regulatory agency personnel, providers, and academics.
