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The Clinical Trial Unit (CTU) has demonstrated an excellent track record in all aspects of the management of local and international multi-centre clinical trials and registries.
The Clinical Trial Unit blends the activities of medical and academic professionals in a synergism that offers a powerful backdrop for the conduct of large multi-centre clinical research projects. These clinical projects are designed to address the treatment and prevention of cardiovascular disease including the application of recent insights into genetic risk factors and the use of molecular biology
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ROCKET AF - Rivaroxaban Once Daily Oral Direct Factor Xa Inhibition Compared with Vitamin K Antagonist for Prevention of Stroke and Embolism in Atrial Fibrillation – A Phase 3, prospective, randomized, double-blind, double-dummy, parallel-group, multicentre, event-driven |
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IDEAL is a prospective, open label, randomized, parallel-group investigation to evaluate the efficacy and safety of enoxaparin versus no enoxaparin in subjects who present to the emergency department with chest pain syndrome and no ECG or biomarker abnormalities, yet high risk clinical presentation. |
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TRANSFER AMI - Patients presenting with acute ST-elevation myocardial infarction (STEMI) require urgent reperfusion therapy, either pharmacological (i.e. thrombolytic therapy) or mechanical (i.e. primary angioplasty) in order to restore flow in the infarct-related artery and arrest the propagating wave of myocardial necrosis..
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AVALANCHE - Avandia + Amaryl or Avandamet Compared with Metformin: a 48 week Randomized, Open-Label, Multicentre Phase IIIB Study to Compare the Effectiveness of Combination Therapy to Monotherapy in Type 2 Diabetes Mellitus Patient
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ATORVO - Atorvastatin Toronto Retinal Vein Occlusion study - Phase III double-masked, randomized clinical trial comparing high-dose atorvastatin with placebo and the improvement in visual acuity in persons with retinal vein occlusion |
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Originate protocol/CRF and study material development |
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Submission to regulatory authorities |
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Central Research Ethics Board Submissions (REB) |
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Management of site local submission to Institutional Ethics/Research Boards |
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Exceptional relationship with sites through prior research interaction, academic reputation of the CHRC and participation in accredited
CME programs |
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An extensive Canadian and American physician contact database |
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Extensive relationship with university and hospital research administrative offices and institutional research ethics boards |
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Regulatory Compliance with Protocol, Sponsor and Regulatory bodies |
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Project Management according to the protocol, GCP and regulatory standards |
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Management of Study Supplies including Central laboratory, drug order, and utilization of nation wide pharmacy distribution systems via SmartCard electronic payment system |
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Site Management:Initiation, monitoring, close-out |
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Electronic tracking systems and reports (enrolment, drug dispensing, study supplies) |
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Data Collection (electronic and/or paper based) and Query Resolution |
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Documents retention/archiving according to regulations, GCP and SOPs |
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Site trouble-shooting |
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Amendment Provision/Support |
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Special reports: provincial/state distribution, enrollment modeling of and study projections |
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Final report to Sponsor, Health Canada, Food and Drug Administration |
Extensive experience in clinical research; Medical background (RN/MD); SoCRA membership and certification.
The breadth and detail of the CTU services is supported by a comprehensive approach to infrastructure and technology. CHRC has developed a clinical project management system that ensures accurate tracking of site activities throughout the clinical trails process. Implementation of this approach and access to our extensive site network has proven to reduce the number of study start-up time delays and reduce study cycle time to completion.
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