Our FDA Consultants provide clinical trial management services that include developing the clinical protocol, setting up and interacting with the IRB (Institutional Review Board), submitting the IDE (Investigational Device Exception), recruiting, and working with the investigator, monitoring the trials, data gathering and analysis, project management, and statistical analysis.
How can weassist you?
Our FDA Consultants work closely with our clients in managing the clinical trials required to collect the clinical data for submission to FDA for premarket approval. The study’s protocol would be based on the FDA requirement for obtaining the approval in the quickest and least expensive manner.
Clinical Trail Process
Our FDA Consultantwill support you in implementation of the complex requirements of a clinical trialplanning and conduct oftrial.Our Clinical Trial process is as follows:
Clinical Evaluation Methodology
Our clinical evaluation related services are as follows:
Clinical Trial Support
Our Clinical experts have experience in conducting medical device clinical trialsbased on the regulatory requirements. We offer the following clinical trial services to our medical device clients:
Please contact us for further information about our Clinical Trial Management Support services. We may be able to assist you.
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