Early Phase Cardiac Safety and TQT - High Point Clinical Trials Center
 

Early Phase Cardiac Safety and TQT

The historical approach to assessing a drug’s effect on cardiac repolarization involved conducting a costly Thorough QT (TQT) study. The guideline revision adopted in late 2015 allows the possibility to obtain reliable ECG data from early stage studies by leveraging high precision QT analysis and exposure-response modelling. Sponsors can benefit from significant cost savings and evaluate the cardiac safety of their compounds earlier in their development strategy.

 

In addition to numerous trials with intense ECG monitoring, High Point Clinical Trials Center research staff have undergone extensive training ensuring that highly precise cardiac safety data is obtained from First in Human Studies and other early stage Studies.

EXPERT TEAM

  • Executive Leadership team with significant clinical pharmacology and drug development experience
  • Board-certified emergency medicine Physician
  • Full-time Paramedics and ACLS certified staff
  • Medical Director involved in 7 TQT studies using moxifloxacin as positive control and 30+ studies with intense QTc monitoring
  • VP of Clinical Pharmacology Services with hands on experience on 20+ studies involving cardiac safety assessments (TQT and early stage)

PURPOSE-BUILT FACILITY

  • Purpose-built and adaptive Participant-centric facility with 24/7 medical oversight
  • Pharmacy staff experienced in the preparation and dispensing of multiple IP formulations
  • Specialized procedure rooms and suitable areas for exercise stress testing
  • 70% of overall experience in Phase 1 studies
  • Numerous Studies inclusive of intense ECG monitoring
  • 17,000+ Healthy Normal Volunteers in CTMS managed database
  • In-house recruitment team supported by mobile recruitment unit
  • Data-driven outreach targeting new and prescreened participants based on health profiles, demographic selectors, and I/E criteria

CERTIFICATIONS & RELEVANT MATERIAL

“Evaluation of a drug’s potential effect on the QT interval can be generated with high confidence using exposure–response analysis of electrocardiogram and pharmacokinetic data from first-in-human studies.”

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“iCardiac Technologies, Inc. in the fall completed a study in collaboration with the U.S. Food and Drug Administration that demonstrated cardiac toxicity in drugs can be detected much earlier in the development process than previously thought by medical professionals.”

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