Support for Japanese companies wishing to conduct early phase clinical studies at one of Quintiles industry leading clinical pharmacology facilities in the US, Europe and Asia (US, UK, India) is provided by the Quintiles Global Sales, Phase I group.
Our clinical group offers the following early clinical development services. These services can be used collectively or on a standalone basis.
- Regulatory Consultation and Clinical Trial Application Services.
- Regulatory Authority(FDA, MPA, EMEA) Meeting Support.
- Investigator’s Brochure and Investigational Medicinal Product Dossier Preparation.
- Protocol Development.
- CRF, eCRF and ICF Preparation.
- Subject Diary Preparation.
- Phase I and Phase IIa (POC) Study Clinical Conduct.
- Data Management.
- Clinical Study Report.
- Clinical Laboratory Testing, including digital pathology.
- Project Management.
- ECG Analysis (provided by the Cardiac Safety Group).
Global Phase I Services
Please contact us to learn how we can provide support with your early clinical development programs.
Global Sales, Phase I
Quintiles Japan, K.K.