What to Know
Clinical study assistance is a fast-growing area of expertise. Think of it as a hybrid of project management, clinical coordination, clinical program management, and data management.
The stringent protocols of new drug testing and technology require a strong knowledge of clinical procedures and workflows to be followed by the research team.
Clinical study assistance is needed from the early development of a drug through site closure.
How We Can Help
As your organization plans your timeline, slating one or more clinical study administrators ensures that all clinical activities adhere to requirements and will receive regulatory approval. Our clinical study assistance consultants can:
- Conduct pre-clinical research
- Manage and support compliant clinical study commencement
- Direct compliance and ensure proper site management
- Coordinate and oversee site closure
- Conduct correct clinical document filing and archiving (digital and otherwise)
- Maintain clinical files post-approval, and for product lifecycle activities