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Clinical Research

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CLINICAL RESEARCH UNIT (CRU)
Our vision is to be the "Benchmark in Cardiovascular Care" by focusing on providing expert care for patients. Our cardiologists are committed to clinical audit processes that identify deficiencies and monitor outcomes. Comprehensive databases are maintained to document the outcomes of patients who have procedures such as angioplasty, radio frequency ablation, device insertion and echocardiography. These audit processes allow our cardiologists to assess their treatment outcomes and also their adherence to guidelines that prescribe optimal care.

In 2012, HeartCare Partners established a dedicated Clinical Research Unit (CRU) to provide clinical research support for their cardiologists. The unit provides a range of research services for sponsored clinical trials, investigator-initiated research projects and clinical quality registries. With access to our sites located at The Wesley Hospital, Greenslopes, Sunshine Coast Unversity and Mater Private hospitals, in addition to numerous country clinics, the CRU is in an ideal position for conducting both inpatient and outpatient research activities.

HeartCare Partners cardiologists have an enviable reputation for quality in the clinical trials service industry and have conducted over 50 research projects covering: phase II to IV clinical trials; device and surgical trials; and clinical quality registries. It is this background and experience that HeartCare Partners takes into the CRU with the ultimate aim of making clinical trials an integral part of health care. They believe that new medications and medical procedures should only be adopted once adequate assessment of their effectiveness, risk and cost has taken place.

CRU SERVICES
The CRU is focused on providing comprehensive, high quality ethical research services which include:

  • Management of clinical trials from phase II to IV (including device and surgical trials);
  • A support framework for investigator-initiated research; and
  • Clinical quality registry establishment, management and reporting.

TEAM
The CRU is staffed by a highly qualified and diverse group of clinicians, nurses and support staff, all of whom are Good Clinical Practice (GCP) certified. Our team aims to ensure studies are conducted in a timely and cost effective manner whilst maintaining the highest quality data and ethical principles. All research conducted by the Unit is conducted in accordance with applicable regulatory requirements and the internationally recognised standards of GCP.

The Clinical Research Team includes:

Cardiologists with expertise in coronary angioplasty, echocardiology, peripheral angiography, intravascular ultrasound, coronary artery intervention, cardiac electrophysiology and stenting techniques.

Clinical Research Coordinators who are qualified registered nurses with diverse clinical skills. All Clinical Research Coordinators have extensive experience using IVRS/IWRS and e-CRF systems and hold current Good Clinical Practice certification.

Clinical Nurse Coordinators who are qualified research nurses with experience in the collection, collation and processing of data for clinical quality services.

Management who provides a supportive work environment and encourages continued professional development to ensure the provision of high quality services.

FACILITIES
CRU's facility includes:

  • 24 hour security monitoring and restricted access;
  • Clinician consulting rooms;
  • Access to biological specimen collection, processing and storage facilities;
  • Access to back-to-base alarmed fridges and freezers for investigational product storage;
  • Secured ambient temperature investigational product storage; and
  • Facilities for sponsor company monitors including an office with access to phone, fax, photocopier and internet access.

REASONS TO PARTNER WITH US – CLINICAL TRIAL EXPERIENCE
HeartCare Partners has worked with many of the world's leading sponsor companies and clinical research organisations and has a proven track record in performing investigator-initiated research and sponsored clinical trials. The below table includes major sponsored clinical trials conducted within the last 10 years.

 

Trial Sponsor (CRO) Design Indication
MAIA Sanofi Aventis Phase III Atrial Fibrillation
IVABRADINE Servier Phase III Anti-anginal
ACACIA Sanofi-aventis Registry Acute Coronary Syndrome
CRESCENDO Sanofi-aventis Phase III Cardiovascular Disease & Metabolic Syndrome
FREEDOM NIH & NHLBI Surgical Cardiovascular Disease
ASCEND Janssen-Cilag/Bayer Phase III Heart Failure
ATLAS Janssen-Cilag/Bayer Phase II Acute Coronary Syndrome
ARISTOTLE Bristol-Myer Squibb (PPD) Phase III Anti-platelet
AVERROES Janssen-Cilag/Bayer Phase III Anti-platelet
ROCKET Johnson & Johnson/Bayer (Parexel) Phase III Anti-platelet
PROTECT Medtronic (PCRG) Device Cardiovascular Disease
DRONE Sanofi-aventis Registry Arrhythmia
STABILITY GlaxoSmithKline Phase III Acute Coronary Syndrome
ALPHEE Sanofi-aventis Phase II Anti-arrhythmic
PREDICT Sanofi-aventis Registry ACS/Bleeding Risk
RECORD Sanofi-aventis Registry Arrhythmia
SPIRIT PRIME Abbott (PCRG) Device Cardiovascular Disease
SIGNIFY Servier (Gleneagles CRC) Phase III Cardiovascular Disease
ABSORB Abbott (PCRG) Device Cardiovascular Disease
ATMOSPHERE Novartis Phase III Heart Failure
CARDIVA Cardiva (PCRG) Device Vascular Closure
COHEREX Coherex Medical (PCRG) Device Left Arial Appendage
PEGASUS AstraZeneca Phase III Cardiovascular Disease
SOLID GlaxoSmithKline (PPD) Phase III Acute Coronary Syndrome
CABANA NHLBI Surgical Anti-arrhythmic
FOURIER Amgen Phase III Dyslipidaemia
QUALIFY Servier Registry Anti-arrhythmic
RESPOND-CRT Sorin Group Device Paroxysmal Atrial Fibrillation
ZERO-AF Boston Scientific Device Paroxysmal Atrial Fibrillation
CLARIFY Servier Regisrty Stable Coronary Artery Disease
ACCENT MRI St Jude Medical Australia Device PPM/MRI

 

CONTACTS

Clinical Research Unit
Unit 26, 43 Lang Parade
Milton QLD 4066

P: (07) 3858 8980
F: (07) 3876 0784
E: This email address is being protected from spambots. You need JavaScript enabled to view it.

Dr David Cross
Suite 91, Level 5
Sandford Jackson Building
30 Chasely St
Auchenflower QLD 4066

P: (07) 3858 8600