Proposals will be reviewed by an ISS Evaluation Committee (ISS EC) consisting of personnel from medical affairs, research and development, biostatistics and safety.

In order to be approved for support by the ISS EC, a study must meet all the following requirements:

1. The defined objective of the ISS is aligned with the current ISS strategy for the medicinal product and therapeutic area.
2. The study is based on thorough scientific knowledge with careful assessment of risks and benefits, addresses a medical need of the population studied, is conducted by suitably trained investigators using approved protocols, and is subject to independent ethical review and oversight.
3. The intent of the study is to obtain scientific data to be shared with the scientific community.
4. The Investigator is committed to execute the contractual agreement and to provide regular study updates, as requested by Sobi.
5. The Investigator must attest that they are capable of and will comply with all relevant GCP-required Sponsor responsibilities and/or other applicable regulations (clinical studies only).
6. The sample size is adequate to the objective of the study and is based on sound scientific, statistical and clinical assumptions (clinical studies only).
7. The Investigator´s commitment to follow Sobi's requirements for ISS support including clinical trial registration in public repositories (e.g. clinicaltrials.gov, as applicable), delivery of a final study report no later than 1 year after the Last Patient Out (LPO) date (clinical studies only).

In addition to the scientific evaluation described above, the ISS EC will ensure that requested funds are justified, reasonable and commensurate with fair market value, and that submitting investigators are eligible to conduct the proposed research. Sobi will not compensate for educational and training activities, purchase of equipment related or unrelated to the study or which could generate revenue to the Sponsor and staff that are not dedicated to the study.

Sobi's local medical representative will present the study proposal to the ISS EC. Therefore, it is highly recommended that investigators contact their local Sobi Medical Science Liaison (MSL) or local Medical Director prior to submitting a study proposal, to address any questions and to ensure the proposal and associated budget are complete and compliant. Investigators who do not know their local Sobi contact should email to [email protected] for assistance and contact details.

Official notification of the Sobi ISS EC decision to 1) approve support, 2) approve support with changes, or 3) decline support will be communicated within approximately two months following each submission deadline, by a Sobi representative. 

Using the Sobi ISS portal , investigators must submit a detailed proposal supported by pre-clinical or clinical data with strong scientific rationale and/or an appropriate review of the literature. The link to the portal can be found below, together with a User Guide Reference. An up-to-date CV of the investigator as well as a detailed budget breakdown must be submitted together with the application.

Once a proposal is reviewed and approved, the investigator will be invited to submit a full protocol for review to ensure consistency with the submitted study application. Please note, approval of a proposal does not imply or guarantee approval of a full protocol. For final sign-off of clinical studies, a copy of the ethical approval must be provided, when applicable. Any support approved by Sobi is initiated only upon a fully executed contract and with all necessary documentation in place. 

If you have any additional questions, please contact us as [email protected].