Clinical Affairs Solutions

FDA Consultants will immediately supplement your organization by providing various clinical affairs solutions, including planning and executing clinical trials that will withstand the review and scrutiny of the authorities including the FDA and International Regulatory Authorities

We provide the following Clinical Affairs Services.

» Initial Research and Analysis

» Pre Clinical Discussions with FDA and the International

» Regulatory Authorities

» Pre IDE/IDE/IND Meetings

» Clinical Strategies and Plans

» Clinical Trial Management Protocol Development

» Clinical Site selection

» IRB and Ethics Committee review

» Data Management and Monitoring, through closure.

» Statistical Services

» Site Training and Initiation

» Clinical Report and Review

We look forward to speaking with you about your specific project needs. Please use the Contact Us form so we can assign the right expertise for further discussion or for a more immediate response call 800 782 0580.