Clinical Trials

Clinical Research

Our Mandate

Translating Discovery into Better Patient Care Streamlining communication and collaboration for the advancement of health solutions and effective patient-care. With the mandate to connect patients and the most advanced therapeutic solutions, our office of Clinical Research provides first-in-man clinical trials, hospital exemptions, and compassionate off-label use.

Quick Links

Clinical Trial Network Service

Overview

Established in 1999, Ichilov’s Clinical Trials Network Services (CTNS) provides comprehensive infrastructure for the implementation of in-patient and out-patient clinical trials throughout Ichilov Hospital. In addition to providing assistance to Principal Investigators in protocol submission, patient recruitment, and quality assurance coordinator backup, CTNS manages a clinical classification patient database to expedite clinical trial requirement compliance.

Therapeutic areas include:

Cardiovascular diseases
Ear, nose and throat
Hematology
HIV
Infectious diseases
Metabolic diseases
Nephrology
Lung diseases
Pain relief
Pediatric Endocrinology
Oncology
Trauma
Surgery
Vascular Surgery

Contact Info

Prof. David Zeltser
Director, Clinical Trials Network Services (CTNS)
Phone: 972-3-6973776
Email: davidz@tlvmc.gov.il
Nurit Platner R.N M.A
Chief Research Nurses/Coordinators
Phone: 972-3-6974961
Phone: 972-3-6973885
Phone: 972-52-4266763
Email: nuritp@tlvmc.gov.il

*CTNS staff is available 24 hours a day.

Information and Resources

Scope of Services
CTNS assists the clinical research processes, including recruitment of patients according to
GCP/ICH guidelines and international regulatory standard trial management compliance.
The office is equipped for conducting clinical trials, with ample space for monitoring visits and
for handling blood samples and pathology specimens.
We offer centralized services, including preparation of source documents, submission of
regulatory documents, and handling of budget and contracts, all tailored to our clients’ needs.

Patient Identification & Recruitment
CTNS employs several methods to identify and recruit trial candidates, including: on-the-
ground cross-department efforts from emergency, internal medicine, and specific outpatient
clinics, CTNS and Ichilov Hospital database search, local advertising, and personal
connections with general practitioners in the community.
Once identified, trial patient candidates are quickly recruited, with CTNS achieving high rates
of informed consent signing, all the while maintaining GCP/ICH guidelines.
Patient Identification & Recruitment
CTNS employs a number of methods to identify and recruit trial candidates, including: on-the-ground cross-department efforts from emergency, internal medicine, and specific outpatient clinics, CTNS and Ichilov Hospital database search, local advertising, and personal connections with general practitioners in the community.
Once identified, trial candidates patients are quickly recruited, with CTNS achieving high rates of informed consent signing, all the while maintaining GCP/ICH guidelines.

Collaborations & Clientele

Startups
Drug manufacturers (generic and innovative)
CROs (subcontractors, single site, and multicenter studies)
Research institutes
Health organizations

Clinical Research Center (CRC)

Overview

Located within Ichilov’s Clinical Trial Network Services (CTNS) unit, the Clinical Research Center (CRC) is Israel’s first and most comprehensive early-phase clinical pharmacology unit, supporting and performing clinical trials under strictly controlled Phase-I standards while addressing specific sponsor requirements. As an integral part of Ichilov hospital, and through its affiliation with Tel Aviv University’s Faculty of Medicine and School of Public Health, the CRC boasts ample opportunity to collaborate with an array of medical disciplines. To date, the CRC has successfully undertaken several hundred trials in collaboration with Israeli and international companies and CROs in the areas of endocrinology, hepatology, neurology, gastroenterology, and others.

Contact Info

Prof. David Zeltser
Director, Clinical Trials Network Services (CTNS)
Phone: 972-3-6973776
Email: davidz@tlvmc.gov.il
Nurit Platner R.N M.A
Chief Research Nurses/Coordinators
Phone: 972-3-6974961
Phone: 972-3-6973885
Phone: 972-52-4266763
Email: nuritp@tlvmc.gov.il

Information & Resources

Welcome to the CRC

Please note: IMPD submission is currently not required for Phase I studies in Israel.

The CRC is located within the Tel Aviv Sourasky Medical Center – Ichilov, one of Israel’s leading hospitals and a national and international referral center for primary and specialty care services. The CRC’s 28-bed and dedicated lab facility are designed to carry out early-phase healthy volunteer and patient studies, focusing on safety, tolerability, pharmacokinetic, pharmacodynamic and immunogenic aspects of novel products (small molecules, biological compounds and vaccines), generic drugs and drug-delivery systems. Some pharmacodynamic assessments have also been carried out in collaboration with other disciplines, e.g. pulmonary function tests, Holter monitoring, audiometry, etc.

The CRC is capable of performing both in-house and ambulatory activities. The hospital’s ICU, ICCU and crash team are within minutes’ walk and are readily available at all times. The CRC is operated by a professional team of dedicated physicians, nurses and laboratory technicians, trained to GCP standards. CRC activities are conducted under rigorous GCP standards and are also compliant with Israeli Ministry of Health regulations. Studies completed in our unit were part of submissions to the FDA and EMA.

Areas of Expertise

CRC expertise includes:

First in Human – healthy volunteers
Dose escalation (single, multiple) – healthy volunteers or patients)
Clinical pharmacology (drug-drug interactions, food effect, etc.) in healthy volunteers or patients
PK/PD
Bioequivalence/absolute bioavailability
Vaccines
Drug delivery systems
Medical devices
Customized study designs

Our Services

Catering to unique sponsor and study requirements, CRC services are flexible and include:

Consulting and/or in-depth involvement in study design
Protocol writing (in collaboration with the sponsor)
ICF preparation
Hard-copy CRFs: design and preparation of CRFs (when applicable)
eCRF (when required)
Preparation and submission of study application forms, presentation to the IRB and Ministry of Health, in accordance with Israeli laws and regulation
Clinical study volunteer recruitment
Study conduct

In addition to meeting client needs, the CRC can also function as a liaison between clients and relevant hospital medical discipline/s when pursuing proof-of-concept or other patient studies.

Our Clientele

Startups
Drug manufacturers (generic and innovative)
CROs (subcontractors, single site, and multicenter studies)
Research institutes
Health organizations

The Clinical Research Advantage with Ichilov

The Tel Aviv Sourasky Medical Center – Ichilov is a research-oriented and university-affiliated hospital. Performing over 500 new clinical trials per year and located in the heart of Tel Aviv, Israel’s largest city, Ichilov provides significant advantages to trial sponsors, including:

Close proximity (walking distance) to the hospital’s ICU and ICCU.
Crash-team on call 24/7.
Availability of advanced ancillary services such as clinical laboratories, diagnostic capabilities (e.g. imaging, EEG, liver fibroscan) and other such services that are only provided by hospitals.
Diverse and relatively large patient populations that can be recruited for early-phase patient studies (e.g. PK, PD sub-studies, proof-of-concept) in collaboration with the various hospital specialty clinics and departments.
Reciprocal collaboration; progression from CRC Phase-I to later-phase studies in other hospital departments/clinics.

Clinical Trials Regulations

Regulatory Procedures for Clinical Trials in Israel

The CRC conducts clinical trials in compliance with Israeli law and Ministry of Health regulations, and in adherence to relevant U.S. Code of Federal Regulations and EC Directive.

Israel Phase 1 Approval Trial Process:

Request for approval is submitted in parallel to the Ministry of Health and the local IRB (electronically)
IRB meeting days are published on Ichilov’s website in advance
Studies must be approved by both Ichilov IRB and the Ministry of Health
Bioequivalence studies may be approved by the local IRB only
A study agreement and insurance policy must be finalized before clinical trial approval can be granted
Average approval time: 2-3 months (bioequivalence studies – 1 month)

Note: Phase 1 clinical trials in Israel do not require an IMPD submission.

Recruitment of Study Participants

CRC and hospital recruitment efforts of healthy volunteers and patients is approved by the the Ichilov IRB and executed in accordance with Israeli Ministry of Health regulations.

Healthy Volunteers:

Understanding that timely participant enrollment is a crucial factor in the successful outcome of a trial, the CRC maintains a volunteer database of over 5,000 individuals while actively recruiting new volunteers on an ongoing basis.

Patients:

Benefiting from Ichilov’s position as one of Israel’s major referral hospitals, the CRC has garnered significant expertise in patient recruitment.

Study Coordinator

Overview

Working alongside Principle Investigators, Research Coordinators ensure the safety and rights of medical trial participants and assess the integrity and reliability of trial information in accordance with Good Clinical Practice (GCP) principles. At any given time, Ichilov employs approximately 120 Research Coordinators throughout various hospital departments.

Applicant Requirements

Bachelor’s degree (preferably in life sciences or clinical subjects)
GCP/CRA certificate holder l

Contact Info

Resumes can be sent to:

Noa Schwartz
Recruitment Department, Human Resources Division
Phone: 03-6974708
Email: noasch@tlvmc.gov.il