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Cardiology

Biotrial provides an end-to-end solution for your cardiology compound from preclinical to early clinical. We will conduct your studies to support the regulatory application and develop robust and well-defined protocols for your clinical trials. Our experienced team of Non-clinical and clinical experts are highly skilled in the scientific methodology, and evolving regulatory requirements.

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Global Approach

Preclinical Services

  • GLP regulatory/early safety derisking (Core Battery)
  • Safety Pharmacology Studies:
    Follow-up and Supplemental Studies (cardiac output, ventricular contractility, vascular resistances, troponin)
  • Validated models for efficacy evaluation in Cardiovascular pathophysiological models of Arrhythmias, Heart Failure, Thrombosis
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Clinical Services

  • Medical expertise & Scientific advice
  • Study feasibility assessment
  • Site selection/qualification
  • Site contracting & payment support
  • Clinical trial management
  • Regulatory services
  • Pharmacovigilance services
  • Clinical monitoring
  • Medical monitoring
  • Central lab services
  • Supply management
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Biometrics

  • EDC and ePRO/eCOA
  • Central Randomization
  • DSMB/IDMC support
  • Data Management
  • Statistical consulting services and statistical analyses
  • CDISC Deliverables for FDA, PMDA (Japan) and NMPA (China) submissions
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Core Lab Services

  • ECG recording
  • QT exploration
  • Telemetry
  • Holter
  • ABPM
  • Cardiac ultrasound / MRI
  • Wearables
  • Blood pressure
  • ECG Monitor / Telemetry
  • Measurement of cardiac output (Systolic Time Intervals, Impedance, Echocardiography)
  • Echodoppler
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Bioanalytical Services

Drug development programs supported by developing and validating bioanalytical LC-MS/MS methods and performing high-throughput analysis for accurate quantification of drugs, from matrices such as blood & plasma, including spleen, and heart tissues.

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Biotrial Therapeutic Area Cardiology Experts Scaled

Cardiovascular Expertise

  • Translational approach from Non-Clinical to Clinical development.
  • Full-service cardiology solutions.
  • Flexible Processes and Solutions.
  • In-house & external cardiologist experts
  • A network of global cardiologists, including subspecialists and interventionalists with diverse specialties and experience through our international investigator network to accelerate patient recruitment
  • Non-clinical and Clinical operational expertise
  • Global trial management teams with extensive experience managing and executing

Indications

  • Angina
  • Arrhythmias (supraventricular and ventricular)
  • Atherosclerosis/Coronary Artery Disease (CAD)
  • Cardiac Contrast Agents
  • Cardiac Tissue Ablation
  • Cardio-oncology
  • Cardiomyopathy
  • Congestive Heart Failure (CHF)
  • Deep Vein Thrombosis (DVT)
  • Duchenne’s Muscular Dystrophy
  • Giant Cell Arteritis
  • Hunter Syndrome
  • Hypertrophic Cardiomyopathy
  • Lipid disorders
  • Medical devices (including pacemakers, ICDs, coronary catheters, coronary stents and ablation catheters and mapping systems)
  • Myocardial Infarction (MI)
  • Myocardial Perfusion
  • Nonischemic Cardiomyopathies
  • Peripheral Vascular Disease (PVD)
  • Primary Hyperoxaluria
  • Pulmonary Hypertension
  • Sickle Cell Disease
  • Acute Coronary Syndrome
  • Hypertension
  • Atherosclerosis STEMI and Non-ST
  • Heart Failure     
  • Stroke
  • Hemostasis, surgical bleeding, for spine, liver, vascular or soft tissue surgery
  • Vascular Access Graft
  • Aortic Aneurysm

Added Value

  • Extensive cardiovascular outcomes trial and adjudication experience
  • From Non-Clinical to Clinical development
  • Flexibility to adapt to the unique needs of each cardiovascular trial.
  • Engage in risk management, regulatory requirements and data management.
Biotrial Therapeutic Area Cardiology Scaled

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