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Clinical Research Unit

DirectorProf Michael Shechter

Head Nurse: Ms. Nava Eisenberg B.A.

Tel: +972-3-5302645

Fax: +972-3-5343882

E-mail: michael.shechter@sheba.health.gov.il

The Division of Cardiology at Sheba is affiliated to the Faculty of Medicine at the Tel Aviv University. The Division has successfully combined up to date medical treatment with clinical and basic research and is one of the leaders in clinical research projects in the Israel and worldwide, maintaining a high standard evident in the many publications in prestigious international medical journals.

The Cardiovascular Clinical Trial Unit functions according to the regulations of Good Clinical Practice, and to the directive of the Israel Ministry of Health for the conducting of clinical trials.

Our cardiologists initiate research studies. Many medical device and pharmaceutical drug companies as well as prestigious international institutions (such as the NIH) choose our unit as an attractive site for clinical trials, based on our professionalism and experience.

Clinical trials conducted at our center are either investigator-initiated or local/international pharmaceutical-initiated trials. We conduct Phase II, III and IV clinical trials according to local national regulations based on the Clinical Trials Law (1999), Good Clinical Practice (GCP) and International Conference on Harmonization (ICH).  Clinical trials are conducted in accordance with the ethical principles (Declaration of Helsinki) and are consistent with GCP and regulatory requirements.

Among the clinical trials we have been involved in many international clinical trials, some with IND submission according to the US and FDA regulations.

Staff include a cardiologist, GP, CCU Research nurses, study coordinators, medical secretaries, technicians and Clinical Research Associates (CRA).

Our mission is to maintain excellence in the cardiovascular clinical research by promoting and highest ethical standards and practices according to GCP, ICH and national regulations.

Our clinical research unit is ranked among the world top recruiters of patients in the fields of heart failure and acute coronary syndrome studies.

Over the past 15 years following local and international audits, including the FDA, our clinical research unit has received excellent reports.

 

Recent Clinical Trials Conducted in the Heart Institute

 

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