RodeConsulting offers experience and services
across a broad spectrum of the therapeutic areas.
We can assist and help you create clinical quality process and system, or
objectively assess existing clinical quality systems.
In the event that issues arise during GCP audits, we provide recommendations to improve your systems and procedures.
Our audit reports are comprehensive and instructional on how to prevent future errors.
QA and Compliance Services
- Performance of independent GCP audits on behalf of the client
ie. Investigator sites, Service Providers/CRO) and Internal processes - Implementation and maintenance of a Quality Management System
- Inspection Readiness
- including ie. training, pre-inspection visits (prepare investigator sites) - SOP design, development and review
- Development of a CAPA system
- Pre-qualification assessments of Service Providers (CRO)
- Customised in-house GCP training of sponsor/CRO clinical staff/Investigator site staff
Clinical & Data Management Services
- Input to and review of Study Protocol
- CRF Design, review and annotation
- Management of outsourced Clinical Monitoring/Data Management
- Data Cleaning/Data Validation
- Input/Development, review of Monitoring/Data Management documents
RodeConsulting | Indelukket 12 | DK-4040 Jyllinge | Phone +45 2810 1385| biro@rodeconsulting.dk