An Investigator-Initiated Studies (ISS) is a clinical study with scientific and medical merit that is initiated, developed, designed, and conducted by a qualified sponsor external to IBSA (e.g. independent Sponsor-Investigator or academic sponsor or scientific no-profit organization) who assumes sole legal and regulatory responsibility for the conduct of the study as defined by applicable international regulations as well as all applicable laws of the country involved. An IIS is conducted without the participation of IBSA group.

• Clinical studies of approved and potential new (unapproved) uses, involving approved or unapproved IBSA product(s)
• Clinical study type: it can be interventional or non-interventional including but not limited to health economic studies, epidemiological research, or analyses of existing data (Real Word Evidence)
• Preclinical research

IBSA support is provided in the manner of either funding, study products or both depending upon the type of study.

IBSA provides financial support and/or product for IISs pursuant to a written Research Agreement, which requires that Sponsor-Investigator complies with applicable local laws, rules, guidelines and regulations. The Agreement clearly outlines the responsibilities of both IBSA and the Sponsor-Investigator throughout the course of the study.

As a condition of accepting support, the Sponsor-Investigator agrees to report to IBSA SAEs and any other safety information as required per agreement for studies involving human subjects.