Phase 1 Clinical Research Center (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.

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

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.

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

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.

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:

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

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

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.