In addition to promoting research collaboration with commercial companies, research groups, and medical/academic centers in Israel and around the world, Ichilov’s Office of Research Contracts handles all legal, insurance-related, and budgetary aspects of contractual agreements for research and development at Ichilov Hospital.
Clinical Contracts and Business engagements unit
This unit, led by Ms. Sahar Haimowitz, promotes and manages research collaborations for conducting clinical trials with commercial companies, medical and/or academic centers and research groups in Israel and around the world.
Our team, in collaboration with professional consultants, handles all legal, insurance and budgetary aspects of contractual engagements regarding clinical trials and studies.
Our mission is to provide complete, broad and flexible solutions for research collaborations using creative and precise answers for various issues.
Our unit handles over 800 agreements per year, which include research agreements, budget amendments, service and consulting agreements, academic collaborations, confidentiality agreements, quality agreements, compassionate use agreements and more.
We support with commercial and regulatory knowledge in regards to conducting of clinical studies in the medical center.
Researchers are invited to contact us for guidance and information in all matters related to these issues.
Contact information:
Clintrials@tlvmc.gov.il
Information & Resources
1. Contract negotiation
The negotiation process for commercial clinical trial contracts begins after study protocol submission to Ichilov’s Helsinki Committee.
2. Clinical Trial Budget
Budget must cover all study expenses, including:
-
- Storage and delivery of study drugs and special preparations
- Personnel: Sub-Investigators, a research coordinator, technicians.
- Hospitalizations/special surgeries within the framework of the study
- Professional counseling by various hospital departments.
- Laboratory, imaging, pathologies etc.
- Overhead (18%)
*Note: When the principal investigator is the study sponsor, and the company provides the research product (drug and/or Medical Device), it must be ensured that the company:
1. Provides the drug in a quantity appropriate for the expected number of participants.
2. Is responsible for the nature and quality of the drug.
To be eligible for Helsinki Committee approval, a budget compliant with the abovementioned requirements must be submitted to the Commercial Contracts Committee via the Israeli Ministry of Health’s online form.
- Liability insurance agreement
- Committee Approval & Trial Fund Management
Following Committee approval, clinical trial approval is granted by Ichilov’s Hospital Director through a signed Form 7.
Once approved, a dedicated research fund will be opened through which all trial funds will be managed.
When do negotiations for the contract start?
After the submission of the study protocol to the Helsinki Committee.
Contract Templates and Agreements
Agreement used may be an existing contract template we provide, or an agreement sent to us by the collaborator.
What is the approximate duration for contract negotiations to final approval?
This time frame depends on the comments and revisions regarding the contract. The budget and the insurance aspects of each side.
Who should cover the budget?
When the sponsor is an external entity, it must be ensured that the budget covers all clinical trial expenses, including:
- Storage and delivery of study drugs and special preparations
- Personnel: Sub-Investigators, a research coordinator, technicians.
- Hospitalizations/special surgeries within the framework of the study
- Professional counseling by various hospital departments.
- Laboratory, imaging, pathology tests
- Overhead (18%)
Contact Info
- e-mail: clintrials@tlvmc.gov.il
- Sahar Haimowitz Director of Contracts & Commercial Engagements
saharha@tlvmc.gov.il
+972-3-6972490 - Ayala Gat Head of Clinical Contracts
ayalaga@tlvmc.gov.il
+972-3-6974697 - Inbal Gafniel Clinical Contracts coordinator
inbalga@tlvmc.gov.il
03-6947261 - Anis Aspir Research assistant
anisasp@tlvmc.gov.il
+972-3-6974703 - Miri Raz Yokel Research assistant
miriry@tlvmc.gov.il
+972-3-6974703 - Maya Yakobov- Research assistant
mayayak@tlvmc.gov.il