EMPIRE-MED Clinical Trials, LLC operate in compliance with FDA regulations and DHHS regulations, guidelines resulting from the International Conference on Harmonization (ICH), Good Clinical Practice (GCP), and potentially the Common Rule, as appropriate. This center is strategically located to an easy access to the patients, physicians and monitors and has been designed to meet the goals and expectations of most clinical protocols, ensuring efficiency and quality our mission.
OUR MISSION
The mission of EMPIRE-MED Clinical Trials, LLC is to enhance and extend life and health for all people affected by the disease. We carry out this mission by conducting rigorous evidence-based clinical research that results in expanding the body of scientific knowledge of the healthcare industry.
Values
Quality, Quantity, Advocacy, Adaptability, Collaboration and Patient Centricity.
Locations:
Our Diverse Community
• Hispanic, White, and African American
•Adult, Adolescents, Pediatric
• Culturally, Ethnically & Economically Diverse
Our Team
• Board Certified Medical Doctor.
• Family Nurse Practitioners
• Nurse Coordinators
• Coordinators
• EDC Department
• Quality Control Department
• Regulatory Department
• Pharmacist Coordinator
• Phlebotomist Coordinator
Quality Assurance Importance
The Principal Investigator is responsible for personally conducting and supervising the conduct of the research and for protecting the rights, safety, and welfare of subjects enrolled in the clinical Studies.
During the course of the studies; starting the day of Site Initiation Visit until the End of Study; a Monthly Quality Control inspection will be conducted by the Principal Investigator to all the Study Documents.
Research Training and qualifications:
1-Human Participants Protections Education for Research
2. Good Clinical Practice Guidelines
3. FDA Guidelines
4. OSHA
5. HIPPA
6. A/E Reporting
7. Data Handling Guidelines
9. ASCLS
10-SOCRA CERTIFICATION (Regulatory Updates for Clinical Research Professionals)
Dedicated to Excellence in Patient Care safety and the Reliability of the Data
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