Research Contracts​

Galia Sasson & Ayala Gat

Contracts & Commercial Engagements

Overview

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.

Contact
Info

Primary Contact

Sahar Haimowitz
Director of Contracts & Commercial Engagements
Email: saharha@tlvmc.gov.il
Phone: 03-6972490

Ayala Gat
Head of Clinical Contracts
Email: ayalaga@tlvmc.gov.il
Phone: 03-6974697

Adi Levy Fishman
Clinical Contracts coordinator
Email: adilf@tlvmc.gov.il
Phone: 03-6974697

Inbal Gafniel
Clinical Contracts coordinator 
Email: inbalga@tlvmc.gov.il
Phone: 03-6947261

Reception Hours

Monday, Wednesday, & Thursday
Between 10:00-12:30pm

General E-MAIL

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.

  1. 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.

  1. Liability insurance agreement
  2. 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%)