SUPPORT ON IITs
TAILORED SUPPORT, SHARED SUCCESS
Setting up and running clinical trials to GCP standards is not an easy task, particularly when you do not have all the necessary structure in place.
CLINERGY works closely with Investigator’s to ensure they have what they need in order to succeed on they IITs through tailored support and oversight. With that, that both research sites and sponsors win by advancing the generation of trustworthy scientific evidence.
SET-UP PHASE
- Protocol /ICF review
- Gap/Risk assessment
- GCP Training
- EDC development
CONDUCT PHASE
- EC package preparation
- EDC/Database set-up
- Study registry on CT databases
- Temporary site staff (visit procedures, data entry, TMF etc)
- Data Management
- Study oversight
CLOSE-OUT PHASE
- TMF reconciliation
- Drug reconciliation
- EC notification
- Update CT registries
- Statistical Analysis
- CSR review
