Clinical Research Consulting Group

ERT brings together industry-leading experts whose unmatched experience and insight are readily available for the benefit of our clients. Our Clinical Research Consulting Group offers the scientific and regulatory expertise that biopharmaceutical, Contract Research Organizations (CROs) and medical device companies need to successfully run their clinical trials.

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.

For more information please see our website, or contact us.