Cardiac Safety consulting, thought leadership and regulatory experience to improve protocols, increase data accuracy, and mitigate risk

ERT’s Cardiac Safety consultants have been influential in supporting pharmaceutical sponsors, medical device companies, and CROs to optimize clinical trial protocol design, bolster data accuracy, and reduce portfolio risks. Our in-house industry experts have worked with regulatory authorities for decades, resulting in a thorough understanding of what methodologies and processes should be employed to ensure quality outcomes. Learn more about ERT Cardiac Safety Consulting.

Cardiac Safety consulting, thought leadership and regulatory experience to improve protocols, increase data accuracy, and mitigate risk

Our in-house industry experts have worked with regulatory authorities for decades, resulting in a thorough understanding of what methodologies and processes should be employed to ensure quality outcomes.

Leading the way in innovation with our EXPERT® Central private clinical research platform, we empower your studies with rapid configuration and analysis, quality-driven Risk-Based Monitoring, and integrated Cardiac Safety, Respiratory, and COA endpoints in one solution.

Cardiac Safety Consulting Services

Specific cardiac safety consulting services from ERT include:

  • Individual and cross protocol cardiac safety review
  • Protocol synopsis for TQT studies
  • Study protocol or ECG schedule design
  • Statistical analysis plans
  • Statistical analysis services
  • Expert medical cardiac safety reports
  • Narratives of adverse events
  • Review or development of Integrated Summary of Cardiac Safety
  • Regulatory representation in conjunction with the sponsor’s in-house team or other external expert
  • Rescue studies

Cardiac safety issues are among the most common reasons for termination of drug development programs, withdrawal of approved drugs, and labeling changes. You can depend on ERT’s consultants to provide strategic value to your study design and to circumvent medical and regulatory issues long before they become critical within the drug development process. Leverage our decades of cardiology and technology thought leadership and regulatory experience to improve protocol design, strengthen data quality, and reduce risk in your next cardiac safety study.

Cardiac Safety Consulting Services

Specific cardiac safety consulting services from ERT include:

  • Individual and cross protocol cardiac safety review
  • Protocol synopsis for TQT studies
  • Study protocol or ECG schedule design
  • Statistical analysis plans
  • Statistical analysis services
  • Expert medical cardiac safety reports
  • Narratives of adverse events
  • Review or development of Integrated Summary of Cardiac Safety
  • Regulatory representation in conjunction with the sponsor’s in-house team or other external expert
  • Rescue studies

Not every heartbeat is the same.
Leverage EXPERT QT™ for our experience, unique analytics and
to potentially replace a Thorough QT study…

Latest from Our Consultants

Webinar: Are Thorough QT (TQT) Waivers Possible? New Approaches in Phase I Cardiac Safety

Meet Our Consulting Team

Robert Kleiman, M.D., Chief Medical Officer and Vice President, Global Cardiology

Robert_KleimanDr. Robert Kleiman is a board certified cardiologist and cardiac electrophysiologist who has performed research in both basic cellular electrophysiology as well as clinical electrophysiology. Dr. Kleiman completed his training at the University of Pennsylvania and was a member of a cardiology practice for 12 years before joining ERT in 2003. Dr. Kleiman is currently ERT’s Chief Medical Officer and Vice President, Global Cardiology. His responsibilities include oversight of ERT’s cardiology services, consulting with external clients and managing overall satisfaction of ERT’s global customers, including all aspects of ERT’s solutions. (Access to some of Dr. Kleiman’s abstracts via PubMed)

Joel Morganroth, M.D., Chief Cardiac Consultant, CS

Morganroth, Joel_sRGBDr. Joel Morganroth is currently Chief Cardiac Consultant, CS at ERT and has served as the Chairman of Board of Directors and Chief Executive Officer for the company. He has consulted for the company since 1977. Dr. Morganroth is a globally recognized cardiologist and clinical researcher who has consulted for our industry for over 35 years. He also served for over ten years as a Special Government Employee for the U.S. Food and Drug Administration and as a consultant to Health Canada. (Access to some of Dr. Morganroth’s abstracts via PubMed)