ERT is proud to bring together our 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.

We understand the importance of regulatory compliance and data accuracy, and we work directly with our clients to ensure quality outcomes right from the start. We are committed to transforming the way clinical trials are run and empowering your expert decisions that help bring safe drugs to market.

Cardiac Safety Consulting —
Development of Strategic Cardiac Safety Plans

Our world-renowned cardiology team is available to consult and provide strategic value on study design, as well as medical and regulatory issues. With more than 70 years of combined industry and regulatory experience, the team is led by two of the most highly regarded thought leaders in the industry: ERT’s chairman and chief scientific officer Joel Morganroth, M.D., F.A.C.C. and ERT’s executive vice president and chief medical officer, Jeffrey S. Litwin, M.D. F.A.C.C.

Cardiac safety is the number one reason for drug withdrawals and labeling challenges. With an escalating need to ensure the cardiac safety of new compounds before they get to market, you can depend on ERT’s consulting for:

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

Drug Safety Assurance

• Design and reporting of Thorough ECG Trials (TET)

ePRO Consulting —
Development of Strategic Plans for Collection of Patient Reported Outcomes (PRO)

Through ERT’s strategic partnership with Healthcare Technology Systems (HTS),* our clients have access to the consulting services of three pioneer professionals in the ePRO industry — Drs. John Greist, James (Jeff) Jefferson, David Katzelnick and Alan Gelenberg.

Our comprehensive consulting services support the study management and implementation efforts of our clients. We create, execute and document a PRO strategy to support the specific objectives of their clinical research.

eClinical Consulting —
Deployment Strategies for Electronic Trial Data

ERT’s strategic focus on electronic data capture and data management for clinical trials includes a range of comprehensive eClinical consulting services:

• Guiding software implementation
• Supporting study setup and developing electronic case report forms (eCRFs), from simple to complex
• Ensuring site qualification and support
• Defining Standard Operating Procedures (SOPs)
• Establishing validation mechanisms
• Implementing system integrations, migrations and upgrades

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.

Client Education

Our team of consultants welcomes the opportunity to share its industry knowledge and expertise to provide ongoing client education. At ERT, we offer extensive course content and consultative services to support study personnel and clients on a range of topics — from the latest in cardiac safety, ePRO clinical research issues and 21 CFR Part 11 compliance to the design of SOPs for client eClinical initiatives.

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*Healthcare Technology Systems, Inc. is a leading authority in the research, development and validation of computer-administrated clinical rating instruments.