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

Magistrate Galia Sasson
Director of Contracts & Commercial Engagements
Email: clintrials@tlvmc.gov.il
Phone: 03-6947261

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

Reception Hours

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

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’s 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, pathology tests
    • Profit component
    • Overhead (18%)

*Note: When the principal investigator is the study sponsor, and the company provides the research product (drug and/or AMAR), 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 above 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?

Immediately after the submission of the study protocol to the Helsinki Committee.

Are there template contracts?

The contract may be an existing version that we already have, or a version sent by an external body.

How long do the contract negotiations take until approval is granted?

The duration of the negotiations depends on the remarks regarding the contract of each of the sides.

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

●      Profit component

●      Overhead (18%)