Summary of Encore “One-Stop” Functions
- Evaluation of study feasibility in the local region involving Encore physicians, clin-op managers, regulatory directors, and PIs.
- Overall study project management, including development of an overall timeline and study budget based on regulatory, drug supply, enrollment, and clinical operations parameters.
- Management of regulatory interactions at local/institutional levels to accelerate IND approvals and optimize timeline management.
- Clinical operations management to seamlessly interact with Sponsor clinical study staff.
- Language translations written and spoken, and training for study sites
- Organization and conduct of investigator meetings.
- Core Molecular/Pharmacogenomics Laboratories. These facilities will offer premium services involving the handling of tissue and serum specimens for analysis of targeted mechanisms and other critical companion/developmental studies.
- Study Site Management
- Pre-identification and qualification of study sites
- Centralized contract negotiation
- State-of-the-art electronic data capture (EDC)
- Rigorous GCP and protocol training and certification