Our research team is experienced with all aspects of clinical investigations and has a thorough knowledge of FDA regulations and ICH guidelines.
We have an excellent Internal, Sponsor, and FDA audit record.
Facilities
· Comfortable, spacious, equipped office space with locked drug storage area and all maintained in accordance with FDA guidelines.
· Outpatient Ambulatory Surgical Center onsite with state of the art equipment.
· All study records are easily accessible and maintained on site.
· Computerized database of over 125,000 patients.
· Physicians affiliated with all thirteen (13) area hospitals.
Timely Enrollment Completion and Data Submission
· Regulatory document completion within two weeks.
· Ability to utilize central or local Institutional Review Boards (IRB).
· Rapid patient recruitment.
Highest Quality Data
· Study specific source documentation insures accurate and thorough collection and verification of information.
· Strict protocol adherence.
· Prompt data entry and case report form corrections.
· Quality Assurance audits on all data.
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