The success of a new product is judged by more than its promising clinical trial results. It needs to achieve its commercial objectives to justify initial investment. Chiltern Late Phase has focus in both local, national studies and large global programs. For example, Chiltern is currently performing registries from 100 patients to over 20,000 patients in a global setting.
Our Global Late Phase Group deploys dedicated specialist project managers and experienced clinical development professionals to deliver services from consultative design and data collection through robust reporting. Our dedicated group focuses on providing specific services designed to support products from the point of approval / marketing authorization through launch and beyond.
Our global expert teams provide Phase IIIb and IV, non-interventional, observational, epidemiology, investigator-initiated trials and registry services worldwide. Chiltern also performs regulatory mandated studies, providing long-term safety surveillance in a real-world setting with dedication and commitment.Chiltern Late Phase capabilities:
- Disease / product registries
- Pregnancy registries
- Post marketing studies
- Post approval safety study (PASS)
- Risk management programs
- Patient reported outcomes
- Phase IIIb / IV studies
- Medical / drug utilization studies
- Expanded access programs (Compassionate use, named patient programs)
- Global call center
- Epidemiologic and retrospective studies