Kendle in Israel

Both Kendle’s global strength in Phase II-IV and its coverage of the Eastern European and Middle East areas have been boosted through our new capabilities in Israel.

Despite the country’s small size – similar to New Jersey – more than 50 pharmaceutical and 200 biotech companies have capabilities in Israel. There are several reasons why it has become a highly-attractive option for those seeking to conduct clinical trials.

The country currently ranks third-highest in Europe for the number of approved drugs in clinical development. Approximately 20 drugs are undergoing approved trials in Israel currently, and 10 of these drugs have already reached Phase II/III.

FDA backing … and the fastest approvals in the world
Israel’s popularity as a location for clinical trials has increased rapidly since 1997, when the country received FDA recognition as an approved site for clinical trials. Another important advantage for choosing Israel is the speed of its regulatory process – the fastest in the world.

An internationally-accredited clinical laboratory, open 24 hours per day, provides comprehensive, central services for clinical trials. In addition, a 30-bed pharmacology unit in Tel-Aviv conducts Phase I, early Phase II and bioequivalence studies.

Each of the country’s 18 major hospitals has its own ethics committee responsible for trial approval However, the average approval time for submissions to European Community regulators is extremely short, at one week. Approved submissions are then sent to Israel’s Ministry of Health, which meets at least once per month, and will request any additional documentation prior to meetings to facilitate immediate decisions.

Expert research staff
The expertise of Israel’s clinical research teams is another good reason to consider conducting a trial there. Israel has a broad base of knowledgeable, educated and experienced project managers and clinical research assistants, and 37 percent of the country’s 5,400 pharmaceutical employees hold an academic degree.

Kendle’s regional expertise

• Cardiovascular diseases
• Dermatology
• Gynecology
• Hematology
• Infectious diseases (HIV, Hepatitis B and C)
• Neurology (stroke prevention)
• Obstetrics
• Oncology
• Urology
• Vaccines