Sponsors

Columbus Clinical Services, LLC is located in Holiday Plaza Shopping Center, two blocks from Florida International University in Miami, Florida. It is strategically located to attract students and patients living in nearby residential communities. Kendall Hospital and Trauma Center is within 3 miles of the office. The Investigator’s private practices are within 20 miles. Patients are seen by the investigators at the Columbus Clinical Services’ office. Patient visits are between 8am and 5pm Monday thru Friday with flexible after-hour and weekend scheduling to accommodate the patient schedules.

Monitoring visits are scheduled at the convenience of the CRA. A private room is provided for review of study records. Our study coordinator is always prepared and available throughout the day to answer any questions.

Columbus Clinical Services is careful to keep current certifications required by the regulatory agencies. We are HIPPA and OSHA compliant and have a CLIA Certificate of Waiver. Our staff is FAA certified and our facility is covered by Federal Wide Assurance (FWA).

Standard Operating Procedures are reviewed and updated at least annually. Staff training records and qualifications are kept current. Our study coordinator is ACRP certified. We are committed to providing an ongoing training program to keep up with the fast changing sponsor and regulatory requirements.

Our lab is equipped with a large capacity laboratory refrigerator that is fitted with alarms and flashing indicator LED to warn of change in temperature conditions. Temperature monitoring is performed daily and documented. All medical equipment that requires calibration is performed as recommended and documented. Study drug and records are stored in a limited access, locked refrigerator or closet that is also temperature controlled.

We use central and local IRBs. The central IRB we use in Miami meets twice a week. Contracts are executed within five days of receipt . Regulatory and study start-up documents are submitted in a timely manner. We are often the first site to receive a Study Initiation Visit.

We have extensive experience using Electronic Data Capture. When source document templates are not provided by the sponsor, we have our own and customize them for the study.

For more information contact Maria Cano, RN, Director of Operations at (305) 871-7010 or email columbusclinical@bellsouth.net