Clinical Operations
Clinical Operations services include:
- Devise clinical development strategies
- CRO selection/Audits/Transfer of Obligations
- Assess Clinical Systems for Compliance
Medical Affairs
Our Medical Affairs group provides our clients with strategic clinical advice to assist in the development of a strong medical program within their overall drug development plan. Here are some of the services Pacific BioDevelopment offers in this arena:
- Provide innovative clinical drug/biologic development strategies.
- Prepare for and participate in FDA meetings, including Advisory Committees.
- Review FDA submissions from a medical perspective.
- Provide interim management and oversight for clients without internal staff.
- Provide Clinical Operations expertise.
Operations and Project Management
Operations and Project Management services include complete operations management and product development expertise. Here are some of the services Pacific BioDevelopment offers in this arena:
- Lead project teams, and manage project budgets and timelines (new product development).
- Assist with due diligence assessments of biotechnology and pharmaceutical investment opportunities (strategic evaluation).
- Provide interim management and oversight for clients without internal staff.