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.
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.
Alvogen Korea does not support the studies described below.
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
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
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.