Research Experience

We are qualified professionals with more than 17 years of cumulative experience in Clinical trials.

Our medical network includes medical specialties such as Family Medicine, Cardiology, Endocrinology, Gastroenterology, Ophthalmology, OB-GYN, Internal Medicine, Radiology, Dermatology, Podiatry, Pulmonology, among others.

Qualifications

1. Full time, On-Site Physician Investigator and Clinical Research Coordinators

2. Full Diagnostic Facility. (i.e. Ultrasound, ECG, X-Ray, Phlebotomy, etc.)

3. Human Specimen Processing Lab Facility (i.e. Blood, Urine, etc.)

4. IATA Certified staff.

5. GCP Certified Staff.

6. Informed consent process, tracking and documentation.

7. Comprehensive subject recruitment & enrollment tracking.

8. CRF completion, drug management, AE review and reporting.

9. Regulatory document processing.

10. Prompt turn-around of regulatory documents, contracts, and budgets.

Recruitment

We have an extensive patient 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.

Quality Assurance

We have a Quality Assurance department to ensure:

1. SOP Development, implementation and annual review for updates.

2. Sponsor and FDA Audit Preparation.

3. HIPAA compliance training for all staff

4. Internal audits.

5. Ongoing staff education. Continuing education and certification.

6. OSHA compliance.

7. Protocol and protocol procedures training and documentation for all staff member involved in a study.