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Clinical Studies for Industry

Shiba | Clinical Studies for Industry

The transformation of biological discoveries into medical treatment calls for a cadre of health professionals skilled in patient-oriented research. Sheba Medical Center Translational Clinical Research supports investigators with excellent qualifications in translational and clinical research to pursue cutting edge biomedical research.

 

As part of its efforts to advance human healthcare, Sheba Medical Center actively promotes translational medicine and cross-disciplinary research through active engagement in human capital development in the biomedical sciences. 

 

Sheba Medical Center is engaged in clinical research and clinical studies with major international pharmaceutical companies, CROs, medical device companies as well as with most Israeli life science companies.  The studies are conducted in the advanced infrastructure facilities and research centers of the Sheba Medical Center, allowing the performance of pre-clinical studies & services as well as clinical research studies & clinical trials. Clinical trials are conducted in accordance with the Protocol, the ICH Harmonized Tripartite Guideline for Good Clinical Practice 135/95 ("GCP-ICH"), the Ministry of Health Guidelines and the Israeli applicable laws and regulations.

 

All research performed at Sheba Medical Center must be submitted to and approved by the Sheba IRB-Helsinki Committee (International Review Board for human and animal trials).  The jurisdiction of Sheba Medical Center IRB is defined by its Federal-wide Assurance document.  The IRB-Helsinki Committee provides initial and continuing review of clinical investigations of the American Food and Drug Administration (FDA) regulated products and complies with the general standards of composition, operation and responsibility.  After receiving approval, the research is conducted under Ministry of Health guidelines and in accordance with the ICH, GLP, American Food and Drug Administration (FDA) approval and Office for Human Research Protection (OHRP).

 

Sheba Medical Center clinician scientists are engaged in a wide variety of clinical trials investigating new approaches for preventing and treating various conditions and diseases. The variety of therapies being studied, ranges from new pharmaceutical drugs and medical devices to behavioral and biotechnology therapies. These trials are performed in close collaboration with scientists and physicians from many areas of expertise across the Sheba Medical Center.

 

Commercial clinical studies may be conducted at Sheba preceding the signing of contractual research agreements.  Researchers and representatives of pharmaceutical, biotechnological and medical device companies interested in conducting clinical trials at the Sheba Medical Center are invited to contact us to finalize agreements, so the studies can begin when protocols are approved by the IRB. 

 

 

For further information:

 

Helsinki Committee:

Ms. Gita Veiber, Coordinator, IRB/Ethics (Helsinki) Committee

Tel : +972 3 5303810

Gita.Veiber@sheba.health.gov.il

 

Clinical trial agreements:

Ms. Vera Leibo Coordinator, Clinical trials contracts and administration

Tel: +972 3 5305754

Vera.Leibo@sheba.health.gov.il