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Services include:
Clinical trial management and co-ordination
- Clinical Trial Planning in accordance with ICH-GCP
- Oversight and governance of clinical trials ( regulated and unregulated)
- Development and maintenance of Clinical trial documentation within standard operating procedures and research protocols
- Clinical trial monitoring
- Inspection readiness
Research nursing support
- Consent processing
- Clinical trial document maintenance during research in order to demonstrate compliance to applicable regulatory requirements and standard operating procedures
- Entering data into research databases including electronic databases/eCRFs
- Ensuring that specific protocol is followed and deviations minimized
- Biospecimen Collection
Protocol development
Assistance and advice with submission of ethical and regulatory documentation
Statistical advice