Since its establishment, the CRC has successfully undertaken several hundred early-phase clinical trials for both Israeli and international companies and CROs.
Many of the studies involve healthy volunteers. Additionally, being an integral part of the hospital, we have accessibility and opportunities to collaborate with the various in-house medical disciplines in conducting early-phase patient studies. These includ areas such as endocrinology, hepatology, neurology, gastroenterology and others. In these trials the CRC contributes its unique experience in performing clinical trials under strictly controlled Phase-I standards. Emphasis is always placed on flexibility and accessibility as we work towards addressing the sponsor’s specific requirements.
It is noteworthy that IMPD submission is currently not required for Phase I studies in Israel.
The 28-bed unit is located within the hospital premises and has a lab facility for processing biological samples. 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.
The CRC is the most experienced site in Israel in conducting early-phase clinical trials, including:
- 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
- Bioequivalence/absolute bioavailability
- Drug delivery systems
- Medical devices
- Customized study designs
The CRC is located within the premises of a major tertiary hospital (Tel Aviv Sourasky Medical Center) in the heart of Tel Aviv, the largest city in Israel. This allows easy accessibilty for clients, volunteers and service providers.
The 28-bed facility is designed to carry out early-phase healthy volunteers and patients 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 activities are conducted under rigorous GCP standards and are also compliant with the Israeli Ministry of Health regulations. Studies completed in our unit were part of submissions to the FDA and EMA.
The services we provide are flexible and cater unique requirements of the sponsor and the specific study.
The following services are providedby the CRC:
- 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 ofHealth, in accordance with the Israeli laws and regulation
- Recruitment of volunteers
- Study conduct
Being a relatively small unit allows us to cultivates needs. ׳ informal, personal and keen interest in the client Being a relatively small unit allows us to cultivates needs. ׳ informal, personal and keen interest in the client
We have been collaborating with a wide range of clients:
- Start-up companies
- Large and small drug manufacturers – innovative and generic
- CROs - as sub-contractors, being a single site or part of multicenter studies
- Research institutes
- Official health organization
Clinical Research at Tel-Aviv Medical Center
The Tel Aviv Sourasky Medical Center is one of Israel’s leading hospitals. It houses around 1400 beds and serves a community of over 500,000 people. It is also a national and international referral center for all major primary and specialty care services. This is a
research-oriented university-affiliated hospital, geared to perform over 500 new clinical trials per year.
The fact that the CRC is located within a large hospital carries significant advantage over independent research units:
- 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 services which may only be provided by a hospital.
- Diverse and relatively large patient populations 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.
- A reciprocal collaboration also occurs: progression from Phase-I in the CRC to later phase studies in other hospital departments / clinics.
The Center is located in the heart of Tel Aviv, Israel`s largest city, which makes it easily accessible to both sponsors and participants.
Clinical Trials Regulations
Regulatory Procedures for Clinical Trails in Israel The CRC conducts its clinical trials in compliance with the Israeli laws and the Ministry of Health regulations, and adheres to the relevant U.S. Code of Federal Regulations and EC Directive, as requested.
Approval process of Phase 1 trials in Israel:
- Request for approval is submitted in parallel to the MoH and the local IRB (electronically).
- Meeting days of the IRB are published in advance in the TASMC website
- The study must be approved by both the Hospital IRB and the Ministry of Health
- Bioequivalence studies may be approved by the local IRB only
- A study agreement and an insurance policy are to be finalized before approval of the clinical trial
- Average approval time: 2-3 months (bioequivalence studies – 1 month)
Phase 1 clinical trials in Israel do not require an IMPD submission.
Being a unique institute in Israel with a long-standingand established record of successful clinical trials, the CRC maintains a continuous dialogue with the Ministry of Health about any regulatory issues that may arrise.
Recruiment of Study Participants
The CRC continuously recruits new healthy volunteers to its panel, realizing that timely enrollment of participants is a crucial factor in the successful outcome of a trial. We currently have over 5,000 volunteers on our list.
Since patient studies are usually collaborative projects with the hospital`s relevant medical fields, recruitment is carried out by the relating specialty clinics. As Tel Aviv Medical Center is one of the major tertiary referral hospitals in Israel, it has large patient populations and is very experienced in patient recruitment for clinical trials.
Advertising for recruitment of both healthy volunteers and patients is approved by the Hospital`s IRB, in accordance with the Israeli MoH regulations.