Clinical Monitoring
Bluestone personnel are experts in all aspects in the conduct of clinical research, using GCP guidelines, HIPAA regulations, and established rules of the New York University IRB, Federal regulations, and NIH standards.
The Bluestone Center for Clinical Research has standardized training and examination modules available on a Bluestone-dedicated intranet for all research personnel from volunteers to biostatisticians to principal investigators. Annual re-certification is required for all research personnel.
Calibration and validation are part of each study with periodic re-assessments for quality control. Bluestone follows closely each step of the clinical studies including:
- Protocol development and review
- Research training and calibration of study personnel
- Study initiation, periodic study review and close up
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