Formed in 1996 as Simbec Israel Ltd., SiGilY Ltd. is an independent, private Israeli company, owned and managed by Dr. Haim Yawetz, Ph.D.

SiGilY Ltd. has an excellent reputation based on its performance of Phase I, early Phase II and bioequivalence clinical trials for leading pharmaceutical companies in Israel, Europe and USA. SiGilY Ltd. has also provided its experience to start-up projects of medicinal products.

SiGilY Ltd. has established close worldwide professional relations with known CRO's, offering its clients, by mutual cooperation, optimal added values for successful performance of studies. These include:

• Independent monitoring of studies on behalf of the sponsors;
• Performing parts of studies in collaboration with other CRO's, e.g. study design, protocol production, clinical, bioanalytical, statistics, pharmacokinetics, data management, report writing and regulatory issues;
• Subcontracting CROs to manage Phase II/III studies under SiGilY Ltd. overall responsibility.
• Participation in multi-center projects conducted by other CRO's.

SiGilY Ltd. has also established contacts with large outpatient health insurance funds in recruitment of ambulatory patients for various studies.

SiGilY Ltd. has arranged additional services to overseas clients required for performance of studies in Israel. e.g. insurance and liaison with regulatory authorities.

The SiGilY Ltd. CRC is a Phase-I Clinical Pharmacology Unit located at the Tel-Aviv Sourasky Medical Center (TASMC). It is, in fact, the only dedicated Phase-I unit in Israel.

The CRC was founded in the wake of an increasing awareness that Israel should become more actively involved in early-phase clinical trials. A recent boost to this trend has been made by the agreement of the FDA to approve clinical studies performed in Israel, provided they adhere to the appropriate GCP standards.

Our 30-bedded unit is situated within the hospital premises. It combines the capability of carrying out phase-I and bioequivalence studies involving healthy volunteers as well as early-phase studies with patients from the various Hospital disciplines. The CRC was established with the blessing of the Israeli Ministry of Health, and enjoys the full support and co-operation of the Hospital's management.

The personnel operating the CRC comprises of physicians, nurses and technicians, trained to GCP standards.

Since its establishment, the CRC has successfully undertaken clinical studies for both Israeli and international pharmaceutical companies and CROs. Through collaboration with the hospital's various specialties and with other hospitals in Israel, the CRC has access to patients with various diseases e.g. liver diseases, kidney diseases, asthma, neurological conditions, cancer, etc. This has led us to undertake a number of Phase-IIa patient studies, with the added advantage that the latter are conducted in a strictly controlled Phase-I setting.

The fact that the CRC is located within a large general hospital carries a significant advantage over independent CRC's:

• The Tel-Aviv Sourasky Medical Center is one of Israel's leading hospitals. This university-affiliated hospital houses around 1000 beds and serves a community of 400,000 people. It operates with the most advanced medical equipment and provides the whole range of medical services. http://www.tasmc.org.il/main/index.ie.php3?lang=e
• The daily interaction with the hospital departments and the availability of the CRC results in referral for studies commissioned by CROs and pharmaceutical companies through the specific specialties (e.g. oncology, gastroenterology, neurology etc.);
• An opposite trend is also apparent: The Tel-Aviv Sourasky Medical Center is a multidisciplinary, research-oriented and university-affiliated hospital, and this allows SiGilY to promote early Phase trials involving patients of various disciplines and specialties.
• The Center's location was deliberately chosen in the heart of Tel Aviv, in order to achieve the largest possible recruitment source for patients and healthy volunteers, and to facilitate their accessibility to the CRC. In practice, the majority of healthy volunteers are students.

SiGilY Ltd. joined with Analyst Research Laboratories to provide analytical support for bioequivalence, pharmacokinetic and clinical studies.

Analyst Research Laboratories is a GLP (Good Laboratory Practice) accredited, US FDA inspected, analytical contract laboratory. The Company provides analytical services for the pharmaceutical, biotech and chemical industries in Israel and abroad.

Our services comply with the strictest demands of regulatory authorities in the USA and Europe (FDA, EPA, ICH, USP, EP and OECD).

Analyst has a staff of 25 employees, our facilities include 500 sq.m of modern laboratories and offices in the Bio-tech Rabin Park, Rehovot Israel.

A policy of continuous investment in new technology and human resources has led to the latest fully automated instruments, highly trained personnel and a strong, independent, quality assurance unit.

Contact Information

TASMC, R&D Fund
Ya'acov Atsmon, MD, Head of the Clinical Research Center
Tel Aviv Medical Center (Ichilov Hospital)
6, Weitzmann Street
Tel Aviv 64239 Israel
Phone: + 972 3 6973160
Fax: + 972 3 6973935
E-mail:

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