Tzippi Cohen Aharonson is the CEO and Founder of TCA Clinical Research Ltd., a privately owned Israeli clinical research organization (CRO) with more than 20 years of experience managing clinical trials for pharmaceutical and biotechnology companies.
In this conversation we will talk about Israel as a highly recommended country to conduct clinical trials. We will provide useful insights and relevant recommendations for biotech and pharma firms considering Israel to develop their early to late stage clinical studies.
Patricio Ledesma (PL): Tzippi, thanks so much for joining us in this discussion about conducting clinical trials in Israel.
Tzippi Cohen Aharonson (TCA): Thank you for inviting me.
PL: Could you tell us about your academic background and professional experience in the clinical research field?
TCA: I was born and educated in Israel, receiving a Bachelor of Science in Chemistry (cum laude) from the Hebrew University, Jerusalem, and then a Masters in Neuro-Biochemistry (cum laude) from Tel Aviv University. My Clinical Research career began in 1996 and included 10 years of clinical trials positions for Quintiles Transnational Ltd. (known today as IQVIA) and Pharmanet Ltd. (known today as Syneos Ltd.). I had the great opportunity to perform my initial training in the United Kingdom for 6 months at the headquarters of ClinTrials Research Ltd. (near London), where I had the adventure to experience how to supervise a clinical trial out of Israel.
I founded TCA Clinical Research Ltd. in 2006. Acting as CEO and manager for the company, I also fulfill my passion for onsite clinical research by offering personal freelance services. I have built a respected reputation in setting up and managing successful international and local clinical trials that comply with ICH GCP standards. I’m personally involved in every project ensuring adherence to the strictest quality and safety standards from conception through to implementation.
PL: Israel has gained quite some popularity as a country to conduct clinical trials. Can you give us an overview of the recent history and tradition of Israel in the field of clinical studies?
TCA: Israel is globally renowned as a leading innovator in medical development and quality healthcare. This fact is validated by the very respected and accomplished local medical community, high medical standards, and extensive international success for a multitude of pharmaceutical, biotechnology and medical device companies.
PL: Why should sponsors choose Israel for their clinical trials? What makes Israel attractive?
TCA: Over the years, Israel has emerged as a popular site for conducting medical trials since it offers:
- Easy investigator and patient recruitment in most therapeutic areas
- Professional medical centers that meet the highest standards and regulatory criteria
- A majority of multilingual GCP trained investigators, study staff, and clinical site personnel
- Support for Electronic Data Capture (EDC) and other advanced technological tools
- Short approval process cycles
- Reduced study costs as compared with western Europe and North America
- Full patient coverage by the national social security system
Many international pharmaceutical companies repeatedly sponsor clinical trials in Israel. They report efficiency, well managed timelines and generally lower costs compared to Western Europe and the USA.
PL: Israel is a country geographically located far from the world’s main clinical trial markets (e.g. United States and Europe). Does this have an impact on clinical operations and trial logistics in Israel?
TCA: Israel counts on excellent infrastructures, resources, and communications to guarantee high quality clinical operations in clinical trials of any size. Clinical trial logistics meet the highest standards as well.
PL: What are the estimated timelines to have a clinical trial initiated in Israel? How long does it take from study submission to authorities to first patient in?
TCA: Depending on study complexity it takes between 2 to 4 months to start a study.
PL: How does TCA Clinical Research help biotech and pharma companies conduct clinical trials in Israel? What are your key capabilities?
TCA: TCA is fast, efficient and able to manage small and large scale clinical trial projects ensuring on-time and on-budget performance.
TCA provides Clinical Trials Services for:
- Phase I through IV studies
- Advanced therapies studies
- Proof of concept studies
- Non-interventional studies
- Risk-Based Monitoring studies
- Genetic studies
- Sensitive populations studies (pediatrics, soldiers)
TCA’s full range of services includes:
- Project Management
- Clinical Monitoring and Site Management
- EC and Israeli regulatory affairs
- Informed consent forms development
- CRF design
- Study file setup
- Site contract and budget negotiation
- Investigator meetings organization
- Translation and validation of study documents
- Medical writing and documents development consultancy
- Site Study Coordination
- EDC & DM & & Medical Monitoring & Pharmacovigilance (via a partner)
PL: Is TCA particularly strong in specific diseases?
TCA: TCA Clinical Research Ltd. has accumulated more than 20 years of experience, today including the following therapeutic areas – Oncology (Solid & Haemato-Oncology), CNS (Neurology & Psychiatry), Gastroenterology, Gynaecology, Pulmonary, Urology, Nephrology, Gene Therapy, Cardiovascular, Ophthalmology, Genetic Disorders/ Rare diseases, Dermatology, Liver Diseases, Metabolic Disorders, Hematology, Rheumatology and Orthopedics.
PL: Clinical trial sponsors are often interested in having access to top local hospitals and investigators able to ensure high recruitment rates. Are you able to provide this valuable information if sponsors need it?
TCA: TCA is ideally positioned, with long-standing investigator relationships throughout the country, as well as deep familiarity with regional medical centers, procedures and language. Our excellent and trusted local reputation ensures faster and cost-effective results.
PL: How complex is it to import clinical trial drugs manufactured in the U.S. or Europe into Israel? Can TCA help with import paperwork?
TCA: Local depot services have to be used in order to facilitate the import process. TCA provides this service via its partnership with a local vendor of clinical trial supply management services.
PL: Let’s focus on early stage clinical trials. Do you recommend Israel as a territory to conduct phase 1 clinical studies? Why?
TCA: We recommend Israel as a territory to conduct phase 1 clinical studies. In Israel there are several certified and experienced phase 1 units.
PL: What would be your most important advice for sponsors considering the execution of a clinical trial in Israel?
TCA: Work with trusted experts in local regulations, who are familiar with the local processes, authorities, and familiar with the sites and key players.
PL: Tzippi. Thanks again for this interesting discussion. I think your insights will be quite helpful for trial sponsors.
TCA: Thank you Patricio. It was a pleasure speaking with you.
About TCA Clinical Research Ltd.
TCA Clinical Research Ltd. is a privately owned Israeli company representing more than 24 years of experience in addressing the clinical trial needs of both local and international pharmaceutical, biotechnology, medical device and CRO companies. Our expert and reliable services efficiently support and conduct clinical trials from beginning to end for pharmaceutical, biotechnology, medical device and CRO companies.
For further information about conducting clinical trials in Israel, please contact us at: info@sofpromed.com
