WELCOME TO THE EISAI INC. INVESTIGATOR INITIATED STUDIES (IIS) WEBSITE

Please click the following link to learn about Eisai’s current areas of research interest. All Investigator Initiated Study (IIS) application requests and proposals must be in compliance with Eisai's policies and procedures in the categories and for the Eisai marketed products and investigational compounds described on the website and must be in compliance with all applicable governmental regulations and Eisai policies and procedures.

Eisai provides support in the form of funding and/or drug supply to eligible applicants to support scientifically compelling and innovative research consistent with Eisai’s therapeutic or clinical interests and to address legitimate medical or scientific questions impacting/relating to the use of Eisai marketed products or investigational compounds.

Please complete your application using our online templates located in the Documents and Resources tab. Please feel free to Contact us if you have any questions regarding the submission or review process.

• I need information regarding the Investigator Initiated Studies program
• I have questions regarding the comments or status of my proposal
• I experience difficulties accessing the website or submitting a proposal

We are happy to assist with any questions. You may Contact us by phone (866-434-8176) or email (eisai_iisgrants@eisai.com) for assistance.

The IIS Committee is comprised of Eisai Clinical, Medical, Legal, Regulatory, Safety, and Statistics personnel. The Committee will review your application and proposal. Funding and/or drug supplies are provided based on scientific merit and consistency with Eisai’s scientific areas of interest.

The IIS Committee meets regularly to review and discuss proposals. Completed applications must be submitted at least 2 weeks prior to the next scheduled IIS Committee meeting date. In general, you should expect to receive an email communication within one week following the IIS Committee meeting. If you have questions regarding the status of your proposal, you may contact us by phone (866-434-8176) or email (eisai_iisgrants@eisai.com) for assistance.

In order to ensure a complete and timely review, we ask that you please include all fields on the Eisai application form along with the Eisai budget template, if applicable.

Neurology

Applicant completes the Following and submits all documents to the IIS in-box: eisai_iisgrants@eisai.com

• Download and Fill-out the IIS Application
  If requesting funding, download and Fill-out the IIS Budget Detail
• Create and sign an IIS request letter including the following information:
  • A statement requesting the funds and a short description of the IIS request
  • A statement declaring to whom the funds should be paid to (provide contact and address details).
  • Wet ink signature by the appropriate representative
  • The subject line of the letter should read as follows: “Subject: IIS Request; <Product Name>; <study title>"
  • Include full contact, phone, fax, address and email information.
• E-mail the "IIS Application”, "IIS Budget Detail", Cover Letter, CV’s and Medical Licenses for any Investigators participating in the study to the email address listed above

Oncology

To begin your oncology IIS grant application, please click the link below to be directed to the Eisai Oncology IIS VisionTracker portal for preparation and submission of an electronic application. You will be prompted to create a user login and password. Please note that your user name will be your email address.

The following documents will need to be attached in the designated fields or attachment section of the system:

• Budget Spreadsheet using the Eisai Template available for download in the system
• Copy of Your CV
• Copy of Your Medical License (for Clinical IIS)

https://eisai.envisionpharma.com/ienv_eisai/visiontracker/portal/login.xhtml?pgm=IIS

If you are requesting support in the form of funding, please utilize our online template.

1. Please note that the IIS Grant Committee does NOT fund capital equipment.
2. Please note that the IIS Grant Committee does NOT fund personnel/salary costs. However, we will cover tasks/time it will take personnel involved in the study to complete these tasks. Along with this, please provide detail on the tasks (costs for each/percentage of time) each person is going to complete (ie, medical history, informed consent, vital signs, etc.).
3. Please note that if you are requesting funding for a study which includes indirect costs for institutional overhead (OH), the IIS department requests a copy of your site’s policy for these costs.
4. Please note - if your OH is over 25% please send in a copy of your institutional OH Policy

If you have any other questions regarding submission of the study budget spreadsheet, you may contact us by phone (866-434-8176) or email (eisai_iisgrants@eisai.com) for assistance.

If you have any questions, feedback, or suggestions regarding FAQ's, please contact us via email at eisai_iisgrants@eisai.com