Investigator Initiated Trial (IIT)

IIT is a study where the investigator takes sole responsibilities for study-related works, including study planning, conduct, data recording, adverse event reporting, and monitoring.
The investigator takes regulatory obligations as a sponsor for conduct and management of a study, as specified in the laws and regulations.

Requirements for IIT Eligibility

Alvogen Korea may provide pharmaceutical products and study fund for an IIT, if all of following requirements are met as long as it is allowed by the local laws and regulations.

  1. A clinical study conducted with a product of Alvogen Korea available in the market or under development
  2. A study designed in an ethical way
  3. A study that has been well-established plausibility and necessity in conduct of study
  4. A study that has justified study content medically
  5. Feasible study outcomes
  6. A study that has confirmed cost suitability in individual items of the study fund
  7. A study within the range of medical/scientific interest of Alvogen Korea

IIT Type Not allowed

Alvogen Korea does not support the studies described below.

  1. Fundamental study
  2. Non-clinical study
  3. A study that has been confirmed to be in progress or completed.
  4. Duplicate request for support despite an existing study supported by Alvogen Korea

Investigator’s Obligations in IIT

  1. Investigator will take responsibilities for study conception, design, and conduct; safety information report; data analysis/interpretation; and preparation of clinical study report in accordance with laws and regulations.
  2. Investigator must have capabilities of operating a study, including properly trained staff to conduct the study (i.e. GCP, GMP, etc.).
  3. Investigator must implement the agreement settled with Alvogen Korea and submit the study progress report and clinical study report at the mutually agreed timepoints.
  4. In case when study amendment is required, investigator must report the changes to Alvogen Korea in a written form before implantation of the changes.
  5. Investigator must report any safety information to competent authority and Alvogen Korea.
  6. Investigator must obtain approval for the study from relevant organizations (e.g. IRB, MFDS, etc.) in accordance with the regulations.
  7. Investigator must publish the study results in literature.

Alvogen Korea’s Rules for IIT Support

  1. Alvogen Korea will exclude involvement of Sales and Marketing Departments from review and processing of IITs.
  2. Alvogen Korea will not provide any study support exceeding the fair market value.
  3. Alvogen Korea will pay the full contracted amount only when the contract obligations are fulfilled and strictly prohibit support for any cost unrelated to the conduct of study.
  4. Alvogen Korea will prepare an Expenditure Report based on provision of economical income quarterly in accordance with regulations for transparency of our support.

How to apply for IIT Support

Proposal template and CV template can be downloaded below.

Please, send us the investigator’s curriculum vitae and proposal of the study you would like to propose to the email address below

alk-cs&pms@alvogen.com


The investigator’s curriculum vitae and proposal will be reviewed and review comments will be given to investigator within one week from the date of submission.

If you have any question about IIT, please call, 02-2047-7798 or 02-2047-7825

CV Form

IIT Proposal Form

IIT Review and Subsequent Procedures

The submitted proposal will be reviewed and discussed in a relevant committee based on the medical value and connectivity to Alvogen Korea’s research and development plan.

When the review result is approval, the investigator will prepare the final protocol based on the approved proposal and obtain approval from the relevant organizations (e.g. IRB, MFDS).

Then, agreement with Alvogen Korea will be settled. In accordance with the agreement, the study will be conducted.

At the end of the study, the clinical study report will be submitted to Alvogen Korea. For a study approved with literature publication plan, the obligation of literature publication should be fulfilled.