Early Phase Clinical Research Center
Research & Development
The Clinical Research Center is an early-phase clinical pharmacology unit located at the Tel-Aviv Sourasky Medical Center . It is the first dedicated Phase-I unit in Israel, founded in the wake of increased interest and extent of early phase trials in the country. 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.
Facilities
The 28-bed unit is located within the hospital premises, and access is limited to CRC personnel and participants only.
Location within a Large Hospital
The CRC is part of one of Israel’s leading hospitals. The Medical Center houses around 1300 beds and serves a community of over 400,000 people.
This university-affiliated hospital is a national and international referral center for all major primary and specialty care services.
- Access to a large number of special (patients populations for rapid recruitment, using the Hospital's unique Clinical Trials Network Services).
- Joint projects with other hospital disciplines in Phase I and Phase IIA studies with patients.
- Availability of state of the art diagnostic and imaging equipment (CT, PET-CT, MRI, fMRI etc.).
- Within minutes walk from the hospital’s ICU and ICCU. The hospital’s crash team is available 24 hours a day.
- Access to Hospital services: handling biohazard waste, freezer central control, power failure backup, pharmacy, central clinical lab).
- Additional medical staff (Physicians, nurses, lab technicians) available for study conduct.
Expertise
- Study design
- Protocol development and preparation
- Design and preparation of Informed Consent Forms
- Design and preparation of Case Report Forms
- Preparation of documents and submission to IRB
- Conducting clinical trials under strict GCP standards
Our flexibility allows us to tailor the needs of the individual client and to work with start-up companies as well as CROs and large pharmaceutical companies.
Experience
The CRC has successfully undertaken clinical studies for both Israeli and international companies. Studies involving healthy volunteers and special patient populations include: Phase I (First into Human, food-effect, drug interactions, new drug delivery systems, pharmacodynamics), vaccines, devices and Phase IIA studies.
Therapeutic areas:
The CRC was involved in clinical trials relating to the following areas:
Analgesic/anti-inflammatory
- Infections
- Allergy and immune system
- Cardiovascular
- Nervous system
- Oncology
- Gastroenterology
- hepatology
- Endocrine/Metabolic System
- Respiratory System
- Genitourinary System
- Vaccines
Personnel
The CRC operates with a specially trained, dedicated team directed by Dr. Jacob Atsmon, M.D.
Dr. Atsmon, graduated the Tel-Aviv University Sackler School of Medicine, specialized in Internal Medicine in Israel and Clinical Pharmacology at Vanderbilt University, USA.
Since 1997 he has served as the Director of the CRC and the Head of the Hospital's Clinical Pharmacology Unit. Dr. Atsmon is regarded as one of the leading experts in Israel in conducting early-phase clinical trials and has gained vast experience in this area.
Dr. Atsmon is supported by a full-time medical, nursing, laboratory and QA staff headed by
Mrs. Kirsten Yakira Haim, RN.,B.S. who studied in the United States and acquired extensive experience in nursing both in an emergency department and a cardiovascular telemetry monitored unit.
She has a unique experience in managing clinical trials under GCP standards and is one of the first nurses in Israel to administer a dedicated clinical research center. Supplementing this core team are part-time hospital staff, trained inclinical research by the CRC.
Volunteers
The CRC has established a large volunteer database of over 3000 adult healthy volunteers. Patients for early phase studies are recruited in liaison with the relevant hospital clinics and departments.