At BioMed Research Institute our qualifications include:
Full time, On-Site Physician Investigator and Clinical Research Coordinators
Preparation of source documents.
Comprehensive subject recruitment & enrollment tracking.
CRF completion, drug management, AE review and reporting.
Informed consent preparation/review.
Regulatory document processing.
IATA Certified staff.
Human Participant Protections Education for all Staff
Prompt turn-around of regulatory documents, contracts, and budgets
Subject recruitment plan and execution
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.
We have implemented a Proactive Patient Retention Program with patient feedback that includes anonymous surveys and follow up end of visit phone calls.
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 has experience in Electronic data transfer – (ECG, PFT, glucose monitors, ABPM, etc.).
We have a Quality Assurance department to ensure:
SOP Development, implementation and annual review for updates.
Sponsor and FDA Audit Preparation.
HIPAA compliance training for all staff
Ongoing staff education. Continuing education and certification.
Protocol and protocol procedures training and documentation for all staff member involved in a study.