782 NW 42nd Ave Suite 4, MIAMI, FL 33126
SPONSORS.
It is our goal to provide outstanding services to our patients and sponsors.
Our qualifications include:
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Full time, On-Site Physician Investigator and Clinical Research Coordinators.
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Preparation of source documents.
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Comprehensive subject recruitment & enrollment tracking.
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CRF completion, drug management, AE review and reporting.
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Informed consent preparation/review.
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Regulatory document processing.
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IATA Certified staff.
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Human Participant Protections Education for all Staff.
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Prompt turn-around of regulatory documents, contracts, and budgets.
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Subject recruitment plan and execution.
Recruitment:
Our recruitment staff maintains a detailed database that allows us to access suitable volunteers. We know our patient population and maintain a good relationship with physician in our area for patient referral.
Data Management Capabilities
Web based data capture. It is our goal to complete data entry within 72 hours of subject visits and query resolutions within 72 hours.
Our personnel have experience in Electronic data transfer – (ECG, PFT, glucose monitors, ABPM, etc.).
We have a Quality Assurance Department to ensure:
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SOP Development, implementation and annual review for updates.
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Sponsor and FDA Audit Preparation.
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HIPAA compliance training for all staff.
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Internal audits.
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Ongoing staff education. Continuing education and certification.
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OSHA compliance.
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Protocol and protocol procedures training and documentation for all staff member involved in a study.