Transcript CRC-Presentation

Tel Aviv Sourasky Medical Center (TASMC)
Research and Development Division
Overview
Tel Aviv Medical Center
1000-Bed Capacity
University-affiliated
Serves a population of over 400,000 people
All modern medical specialties
State-of-the-art equipment
Extensively involved in medical research
Capabilities
Basic research
All phases of clinical trials
Capabilities……
Clinical Research
Phase I Trials
Phase IIa Trials
TASMC
Early Phase
Research Center (EPRC)
Phase II Trials
TASMC
Clinical Trials
Network Services (CTNS)
EPRC
EPRC
Phase III Trials
EPRC
Description
• Established in 1997
• Operating under strict GCP standards
• Phase I, Phase IIa and bioequivalence studies
• Dedicated staff
• Staff trained under GCP standards
• Over 2000 healthy volunteer pool
EPRC
Layout
•A 28-bed pharmacokinetic unit
•Lab facility for processing biological
samples
•Ambulatory treatment facilities & office
services for volunteers
EPRC
Experience
Over 250 studies related to the following clinical areas:
» Allergy
» Bone metabolism
» Cardiovascular
» Central nervous system
» Diabetes
» Gastrointestinal
» Urology
» Infectious diseases
» Inflammatory conditions
» Lipid metabolism
» Oncology
» Psychiatry
» Pulmonology
» Topical drug administration
» Vaccines
EPRC
Expertise
• Study design, protocol development and
conducting clinical trials
• Flexibility in meeting individual client’s
requirements
• Competitive costs
EPRC
Location Within a Large Hospital
Advantages
• 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
EPRC
Location Within a Large Hospital
Advantages
• Protocol approved through hospital’s IRB
• Joint projects with various hospital departments
- Oncology
- Infectious diseases
- Neurology
- Cardiology
- Gastroenterology
- Psychiatry
- Pulmonology
- Intensive care
• Phase IIa studies more accessible
• Rapid recruitment of hospitalized and ambulatory patients
through the hospital’s Clinical Trials Network Services
• Public opinion more favorable to clinical trials carried out in the
premises of a major hospital
EPRC
Location Within a Large Hospital
EPRC
Joint Operations
The EPRC operates in liaison with other bodies, local and
international, according to the Sponsor’s requirements:
• Central laboratories for safety screens
• GLP bioanalytical laboratories
• CROs for data management and monitoring on
behalf of the Sponsor
• Other medical institutes for recruitment of additional
patients
EPRC
Additional Services
The EPRC also:
• 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 substudy)
EPRC
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.
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.
Mrs. Kirsten Yakira Haim, RN.,B.S. studied in the United States and acquired
extensive experience in nursing both in an emergency department and a
cardiovascular telemetry monitored unit. She has acquired unique experience
in managing clinical trials under GCP standards and is one of the first nurses in
Israel to manage a dedicated clinical research center.
EPRC
Strategic Objectives
EPRC is looking for strategic partners to
form alliances with pharmaceutical and
biotechnological companies as well as with
CROs, to create long-range cooperation
and key account relationships.
EPRC
Contact Information
Tel Aviv Sourasky Medical Center
Clinical Research Center
6 Weizmann St. Tel-Aviv 64239, Isreal
Tel: +972-3-6974875, Fax: +972-3-6973935
E-mail: [email protected]
www.tasmc.org.il
EPRC
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