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Contract Research Organisation


The services provided by the CRO of the HCRS include, but are not limited to:

Clinical Operations Services

  • Study set up
  • Feasibility & Investigator Selection
  • Project Management
  • Monitoring of Investigational Sites
  • Assistance in Safety Reporting
  • Study Close out

Medical Affairs

  • Clinical protocol design (also ICF/CRF/patient questionnaire/patient diary/patient leaflet/manual)
  • Safety review
  • Medical support & advice during study conduct
  • Translation of medical documents
  • Clinical study report preparation

Regulatory Matters in Clinical Research

  • RA submission
  • CEC submission
  • Local EC submissions
  • Ethics & Regulatory Authorities reporting
  • Agreements negotiation (YPE, Universities, Private Hospital)
  • Investigator payment handling

Data Management & Statistics

  • Data entry
  • Statistical Analysis
  • Statistical report

Training

  • Investigator Meeting & Congresses organisation
  • Study specific & ICH/GCP training

Secretarial Services

  • Site coordination
  • Telephone contacts and progress reporting

 

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  1. Assali A, Vaduganathan M, Vaknin-Assa H et al. Comparison of Late (3-Year) Registry Data Outcomes Using Bare Metal Versus Drug-Eluting Stents for Treating ST-Segment Elevation Acute Myocardial Infarctions. Am. J. Cardiol. 2012; 109:1563-1568 … more More
  2. Martinoni A, De Servi S, Politi A et al. Defining high-risk patients with ST-segment elevation acute myocardial infarction undergoing primary percutaneous coronary intervention: A comparison among different scoring systems and clinical definitions. Int. J. Cardiol. 2012; 157:207-211 … more More
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  9. McEntegart MB, Kirtane AJ, Cristea E et al. Intraprocedural Thrombotic Events During Percutaneous Coronary Intervention in Patients With Non–ST-Segment Elevation Acute Coronary Syndromes Are Associated With Adverse Outcomes: Analysis From the ACUITY (Acute Catheterization and Urgent Intervention Triage Strategy) Trial. J Am Coll Cardiol 2012;59: 1745-1751 … more More
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