Genomics in Clinical Trials
Genomics within clinical trials pose special challenges from an analysis and regulatory perspective.
Study Design
Proper study design and analysis plans are critical for clinical trials that include genomic data collection. We can help you design your studies to maximize the benefit of these technologies.
Genomics Data Submission
With a background in both regulatory issues and genomics, Elashoff Consulting can provide guidance on your submission of genomic data to the FDA. Michael Elashoff has worked with the FDA to help them set standards for genomic data submissions.
Analysis
We have performed validated analyses of clinical genomics studies to comply with regulatory requirements. Please contact us for more information.
