Investigator-Initiated Studies (IIS)
IBSA group Portal
IBSA group (IBSA) believes that independent research activities conducted by qualified investigators plays a key role in expanding the medical and scientific knowledge related to a company product and/or its associated disease areas and in complementing IBSA-sponsored research.
To provide support, IBSA evaluates the scientific merit, the robustness of design, the feasibility, and the overall alignment with IBSA’s research and product specific strategy.
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.
For a new proposal submission, we encourage you to preliminary discuss it with the IBSA group local medical/scientific affairs contact. If you do not know who your appropriate contact is, please send an e-mail to IIS@ibsa.ch.
In order to submit a new application, manage a submitted/approved study, or view an existing application through the portal please log-in or sign up if you are not registered yet.