Designing, Organizing, and Executing Bioequivalence Studies and Phases I to III Clinical Trails

BBC specializes in consulting relating to bioequivalence studies and phase I to III clinical trials, which will be a great advantage of our clients to accomplish clinical trials and achieve current Good Clinical Practice (GCP) requirements. BBC experts own rich knowledge and practical industry experiences in bioequivalence studies and phase I to III clinical trials as well as FDA GCP rules and regulations which assure that clinical trials of our clients can reach the utmost level requirements and comply with all related regulations.

Service

• Drafting protocols for phases I to III clinical trials
• Selecting clinical trial sites
• Recruiting key opinion leader (KOL) in the field
• Assistance to clinical trial protocol approved by Ethics Committee
• Volunteers’ recruitment and volunteers with informed consent form
• Monitoring clinical trials
• Clinical trial site and investigators audit
• Designing and executing GCP compliance procedures
• SOP review and writing
• Monitoring clinical trials and handling clinical data
• Mock pre-approval inspection
• Correspondence with regulatory authorities

Link to "Services" for more information.