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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