Cardiac Safety

A thorough QT/QTc study should be well-controlled, with mechanisms to deal with potential bias, including use of randomization, appropriate blinding, and concurrent placebo control group. ERG delivers.

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sites with cardiac safety expertise

QT/QTc studies are a key component of the safety database for any new drug application—so it is critical that all pooled data be developed in similarly rigorous studies. The standardized collection policies across the ERG network enable us to deliver data that can be collected swiftly, then harmonized with confidence.

Demonstrated Expertise in Multiple Study Types

  • Thorough QT/QTc studies
  • Crossover or parallel group studies to assess the potential of a drug to cause QT/QTc interval prolongation
  • Collection of ECGs at multiple time points under tightly controlled settings that target a broad range of doses early in development
  • Polarization studies

ERG’s Experienced Cardiac Safety Team


Demonstrated Expertise in Multiple Study Types

  • Thorough QT/QTc studies
  • Crossover or parallel group studies to assess the potential of a drug to cause QT/QTc interval prolongation
  • Collection of ECGs at multiple time points under tightly controlled settings that target a broad range of doses early in development
  • Polarization studies

Specialized Procedures for Cardiac Safety Clinical Research

At ERG clinical research sites, cardiac safety trials are conducted with strict attention to eliminating noise. In order to provide patient surveillance related to a potential cardiac risk, we customize room configurations to our client’s needs. The sites themselves are specifically designed to control temperature, humidity, noise levels, and other conditions that might cause variation in data collection. We carefully train staff to ensure consistent site-to-site data acquisition practices and testing techniques, including skin preparation, lead placement and patient position; we also create blinded conditions to establish the degree of inter- and intrareader variability to maximize end-data accuracy. We typically use ambulatory ECG monitoring or standard 12-lead ECGs, but we can also use bedside monitoring, including pulse oximetry, ECG, and vital signs; we regularly service and calibrate all equipment.

Per FDA Guidance, the magnitude of QT prolongation at therapeutic exposures will influence the intensity of ECG monitoring in late-phase trials, underscoring the importance of precision in TQT studies.

Targeted Patient Recruitment

Thorough QT/QTc studies are typically conducted in healthy volunteers. ERG’s database has more than 5,000. However, some drugs, such as neuroleptic agents and chemotherapeutics, have issues of tolerability that require study in specialized populations. ERG’s database has more than 215,000.

Spotlight

Top Investigators icon

Jim Aukstuolis, MD

  • Investigator on 180+ trials for adult and pediatric/adolescent populations
  • State-Appointed Member, Children’s Behavioral Health Care Commission
  • Board certified in adult and child psychiatry
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Doctor icon

Robert Billingsley, Jr, MD

  • Contributed to 80+ clinical trials in psychiatric disorders
  • Psychiatrist, Private Practice; Consultant, Veteran’s Administration Medical Center; Attending Psychiatrist, Piney Ridge Center
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Research icon

Case Study: QTc trial for schizophrenia therapy

  • Top enroller with 97% completion rate
  • 100 study participants, 30% female
  • 10-week trial, including 17 days inpatient
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