Scientific Regulatory Representation
Understanding and adhering to changing regulatory standards is essential for successful clinical trials and outcomes. From study initiation and planning, to representing the sponsor before the U.S. Food and Drug Administration (FDA) and other regulatory agencies, our professional consultants make certain that our clients’ studies meet every compliance requirement.
ERT’s consulting group offers an exceptional range of regulatory expertise to develop SOPs, provide validation services and/or audit existing clinical data systems for compliance. In addition, ERT consultants are always available to help clients interpret regulatory requirements, including 21 CFR Part 11 and ICH-E14 to assist in adjusting data-related processes and procedures to ensure continued compliance.
Development of Strategic Plans
Comprehensive Planning
- Individual cardiac safety study design
- Overall strategic planning for cardiac safety at the compound level
- Design of ECG and Holter technologies
Expert Guidance
- Protocol design
- Statistical plans
- Statistical analysis
- Expert medical reports
- Patient safety reports
