Cardiovascular Expertise

Inclusion of standardized cardiovascular imaging endpoints in clinical trials is becoming increasingly valuable, often resulting in an accelerated understanding of a drug's effect on cardiovascular safety and efficacy. However, imaging endpoint assessments are highly dependent upon image acquisition protocol, image reconstruction and processing parameters, measurement technique, assessment guidelines and image reviewer expertise. Consistent, high quality imaging data, thorough site qualification and training processes, image data quality checks and reduced variability through independent review are the keys to success for a study with imaging endpoints. As a leading Imaging Core Lab for clinical trials with cardiovascular safety or efficacy endpoints, Perceptive Informatics offers broad experience and expertise in handling small and large scale studies in multiple therapeutic areas and imaging modalities.

Our cardiovascular experience includes the following indications:

  • Cardiovascular safety endpoints in oncology, neurology, diabetes, obesity and other indications
  • Arrhythmias
  • Arterial hypertension
  • Atherosclerosis
  • Coronary artery disease
  • Deep vein thrombosis
  • Heart failure
  • Myocardial infarction
  • Peripheral vascular disease
  • Valvular heart disease
  • Ventricular hypertrophy

Perceptive Informatics has extension experience supporting the following modalities:

  • Ultrasound
    • Echocardiography
    • Carotid Ultrasound including IMT assessment
    • Venous Ultrasound
    • Intravascular Ultrasound (IVUS)
  • Nuclear Imaging
    • Single photon emission computed tomography (SPECT)
    • MUGA
    • Positron emission tomography (PET)
  • Invasive Angiography
    • Digital Subtraction Angiography (DSA)
    • Quantitative Coronary Angiography (QCA)
    • Venography (Phlebography)
  • Magnetic Resonance (MR) Imaging
    • Diffusion/perfusion MR
    • Cardiac MRI
    • Magnetic Resonance Angiography (MRA)
  • Computed Tomography (CT)
    • Perfusion CT
    • Cardiac CT (including coronary calcium scoring)
    • High Resolution CT (HRCT)
    • Computed Tomographic Angiography (CTA)

 

Cardiovascular Services

The Perceptive Informatics medical imaging experts provide consultation on developing the imaging component of protocol and analysis design and guide independent review charter development. Perceptive Informatics ensures a standardization of image acquisition through site training and qualification, and collection and processing of all images in a central repository. Rigorous demonstration, training and testing of reviewers are performed prior to independent review. These practices enable the independent and unbiased evaluation of images.

Collaborating with Perceptive means access to our global key opinion leader network. Perceptive Informatics has worked with over 30 world-renowned medical centers for clinical trial programs. The Perceptive Informatics list of subcontracted collaborators includes over 30 sub-specialized experts. The selection of reviewers is based on their proven record of adherence to quality and timelines, and governed by Perceptive Informatics standard operating procedures.

Perceptive Informatics provides imaging services tailored to the needs of your cardiovascular clinical trial. Let us help you succeed through:

  • Global image processing and image analysis capabilities allowing for near non-stop image processing around the globe for high-volume imaging studies
  • Our clinical trial radiologist, cardiologists and imaging experts will consult with you to help you solve imaging issues, from study design to image quality and regulatory filings
  • In-house medical writing team for charter development with the highest quality and oversight and expedited charter development as needed to meet regulatory timelines
  • Large network of sub-specialized independent reviewers in North America and Europe, as well as the ability to select additional key opinion leaders in the review process
  • Comprehensive medical image management services including site qualification, centralized image collection and processing, independent image review and preparation for regulatory submission
  • Our proven systems and processes ensure accurate collection of images with on-going quality checks and feedback to the sites
  • As active members of your project team, the Perceptive Informatics medical imaging experts will provide focused support not only at the development and start up of your study, but also throughout your study to answer questions and provide guidance
  • Perceptive provides management of digital image data archives with access by sponsors and packaging for regulatory agencies

Early Phase Trials

For early phase trials, Perceptive offers the same extensive experience and level of service but with scaled-down and flexible delivery/analysis options, as well as scientifically relevant approach. Our early phase options are cost-effective and reproducible. The Perceptive Informatics team will work with sponsors to target and identify early signals for efficacy and safety while helping to determine early go/no-go decisions.

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