SERVICES

Strategic Planning Services

- Product and medical needs assessment

- Product development planning

- Business planning

- Regulatory strategy

Regulatory Consulting Services

l  - FDA negotiation for drugs and devices
l  - Regulatory planning and execution
l  - safety review & adverse experience reporting
l  - safety & effectiveness summary preparation

Clinical Research Services

Phase I, II, III, IV, post-marketing surveillance and registry studies

l  - overall project management
l  - trial design & protocol development
l  - case report form design & production
l  - IRB submission preparation
l  - Informed consent form preparation
l  - investigator meeting set-up & support
l  - site training & support
l  - core laboratory services
l  - study monitoring & management
l  - data entry: paper based, fax, or remote
l  - electronic data capture
l  - data validation & management
l  - Data Safety Monitoring Board
l  - clinical outcomes adjudication committee
l  - statistical planning, analysis, & reporting
l  - publications and presentations