SERVICES
Pacific Clinical Research Group is a full service contract research organization. We also have a niche interest and a wealth of experience in early phase drug and device development. Most components of a clinical trial program are provided by our experienced staff.
These services include:
- Early-phase strategic planning.
- Assessment of pre-clinical programs.
- Introduction to Key Opinion Leaders, and identification of appropriate clinical sites.
- Trial design and development.
- Construction of Ethics Committee submission packages.
- Assistance with regulatory submissions.
- Organization of Investigators’ Meetings.
- Project management.
- Site management and quality assurance.
- Bio-statistical support.
- Data Management.
- Medical report writing.
- Clinical events adjudication.
- Medical management and monitoring.
- Data and safety monitoring board co-ordination.
- Assistance with importation of investigational drugs and devices and compliance with local legislative requirements.
- Regulatory submissions in Australia and New Zealand.
