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Overview

Overview Building better FDA submissions--

Mission Statement Training Experience

Write SOPs GCP audit of CROs and Sponsors Solve Regulatory Problems Write Protocols and Study Reports Improve Submissions (Drugs, Biologics, and Devices) Audit Safety Compliance

In-House Computer Systems - Part 11 Compliance Commercial Software Products - Part 11 Compliance Improve SAS Programming

Part 11 Compliance (3 Classes) SOPs (2 Classes) Regulatory Affairs (7 Classes) Statistical Analysis (2 Classes) SAS Programming (3 Classes) Adverse Event Reporting (2 Classes) Entering Data into ClinicalTrials.gov (4 Classes)

	Statistical Analysis
	Two of Training Classes
	Class Title	Description
1	Adaptive Design & Bayesian Statistics: New Trends in Clinical Trial Design That Encourage FDA Approval	A discussion of the basics for implementing adaptive design and Bayesian statistical analysis.
2	Avoiding Statistical Errors in Clinical Trials: Preparing for FDA Review	A discussion of how to use statistics to improve the design, execution and analysis of clinical trials..