FDA 510(k) Consulting, FDA 510(k) Consultant

What arethe Clinical Trial Management Services provided by our FDA Consultant?

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 Trial Planning & Design
Clinical Trial Study project management
Conducting the Clinical Trial
Clinical Trial Data Management
Statistical Analysis
Evaluation of the clinical study data outcome and prepare the clinical trial reports.

Clinical Evaluation Methodology

Our clinical evaluation related services are as follows:

identification of similar products
conduct research to identify clinical data available in published scientific literature databases.
collection and analysis of clinical data available in the published literature
determining the safety and efficiency of your medical device based on available clinical data.
reconciliation of your product related information with that of the information from the published clinical data
evaluate to determine whether a new clinical study (clinical trial) should be done to collect the required data.

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:

Medical Device Study Design and Protocol Development,
Clinical Studies done based on GCP and ISO 14155 Compliance,
Statistical analysis of data obtained from Clinical Studies,
Clinical Trial Management and Monitoring,
Clinical Trial Data Management,
Clinical Study Audits and Quality Control,
Post-Market Clinical Follow-up Studies (PMCF).

FDA 510K Consulting

Clinical Trial Management Services

What arethe Clinical Trial Management Services provided by our FDA Consultant?

We serve companies of all sizes and product classifications within your budget. Please contact us for a quote for your submission