Director                                 Jacob Atsmon, M.D

Head Nurse                          Mrs. Kirsten Yakira Haim, RN.,B.S

Business Development    Dagiel Dagan, D.M.D, M.B.A,

Overview

The Early Phase Research Center is an Early-Phase Clinical Pharmacology Unit located at the Tel-Aviv Medical Center (TASMC). It is, in fact, the only dedicated Early-Phase unit in Israel.

The EPRC combines the capability of carrying out Phase-I and bioequivalence studies involving healthy volunteers as well as Phase IIA studies with patients from the various hospital disciplines. The EPRC was established in 1997 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 EPRC is comprised of physicians,  nurses, QA personnel,  lab technicians, a recruitment coordinator, secretarial and maintenance staff, trained to GCP standards, headed by Dr .J. Atsmon and Kirsten Yakira Haim RN.

Since its establishment, the EPRC 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 EPRC has access to patients with various diseases e.g. cardiovascular, gastroenterology, cancer, liver diseases, kidney diseases, asthma, neurological conditions, , 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 EPRC is located within a large general hospital carries a significant advantage over independent EPRC's:

• The Tel-Aviv 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.
• The daily interaction with the hospital departments and the availability of the EPRC results in referral for studies commissioned by CROs and pharmaceutical companies through the specific specialties (e.g. Oncology, Infectious diseases, Neurology, Cardiology, Gastroenterology, Psychiatry, Pulmonology, Intensive care)
• The Center 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 EPRC. In practice, the majority of healthy volunteers are students.
• Provision of central services for EPRC maintenance:

                - Disposal of bio-hazard material

                - 24-hour freezer central alarm system

                - Power failure backup

• Additional medical staff  (available for study purposes)-  Physicians, nurses, lab technicians, others
• Safety backup- ICCU, crash team
• Hospital pharmacy services
• Clinical laboratories services
• High standard auxiliary tests

                - Imaging

                - Pulmonary function tests

                - Psychiatric assessment

• Protocol approved through hospital's IRB

Experience

In over a decade the EPRC has gained experience in over 250 studies in various clinical areas (Allergy, Bone metabolism, Cardiovascular, Central nervous system, Diabetes, Gastrointestinal, Urology, Infectious diseases, Inflammatory conditions, Lipid metabolism, Oncology, Psychiatry, Pulmonology, Topical drug administration and Vaccines).

In addition, the EPRC has accumulated expertise in study design, protocol development and conducting clinical trials whilst keeping the individual client's requirements as a priority.

Facilities

A 28-bed pharmacokinetic unit located within the hospital premises, in which access is limited to EPRC personnel and participants only. It is within minutes walk from the hospital's ICU and ICCU. The hospital's crash team is available 24 hours a day.

The unit also has access to lab facility for processing biological samples as well as ambulatory treatment facilities & office services for volunteers.

Additional services

• Conducts bioequivalence, Phase I and Phase IIa trials as a subcontractor for CROs
• Liaises between potential clients and CROs in matters concerning monitoring, data management, etc.
• Participates in large scale studies in which the involvement of a dedicated clinical pharmacology unit  is required (e.g., a PK drug-interaction sub-study)

Key Personnel

• Jacob Atsmon, M.D. 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 EPRC 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.  
• Mrs. Kirsten Yakira Haim, RN.,B.S. studied in the United States and acquired extensive experience in nursing there ranging from working as an emergency department nurse to working  on a cardiovascular telemetry monitored unit. She has acquired unique experience here in Israel in managing clinical trials under GCP standards and is one of the first nurses in Israel to manage a dedicated clinical research center.
• Dagiel Dagan, D.M.D, M.B.A, a graduate of Swiss and Israeli universities, is currently the Business Development Consultant of the EPRC, and has gained extensive experience in clinical development, marketing and sales in the areas of medical devices, pharmaceuticals, and neutraceuticals. He served in executive positions with European and Israeli medical companies.

For more information about The Early Phase Research Center (EPRC) contact us:

Tel: 972-3-6974845

Fax: 972-3-6973935

E-mail: crc@tasmc.health.gov.il