Investigator sponsored studies ISS
Camurus is committed to research to advance medical and scientific knowledge about Camurus’ products and associated therapeutic areas and diseases. An Investigator Sponsored Study (ISS) is an independent and unsolicited interventional or non-interventional clinical study.
Support to an ISS may be in the form of investigational medicinal product (IMP) and/or financial research support. ISS will in general only be supported for Camurus approved and licensed products and not for Camurus products in development. The support requested for the ISS should be at fair market value (FMV) to be approvable.
ISS studies considered for support by Camurus need to fulfill ethical, legal, medical and scientific standards and the sponsor should have adequate training and expertise so that an appropriate benefit-risk balance is maintained for all subjects participating in such studies.
ISS support requires executed agreements confirming the acceptance by the recipient of the conditions of the support they will receive including confirmation that the ISS will be conducted according to the Declaration of Helsinki and ICH GCP, that appropriate ethical committee and regulatory approval will be received before commencing the study, that appropriate safety reporting will be done to regulatory authorities and to Camurus through a safety data exchange agreement, that Camurus has the right to review any protocols and amendments and abstracts or manuscripts to assure medical and scientific correctness, that no confidential product information is disclosed, and that the agreed terms for intellectual property and use of data generated in the study with Camurus product are accepted.
ISS support may under no circumstances be given with the intent of, directly or indirectly, implicitly or explicitly, influencing or encouraging the recipient to purchase, prescribe, sell, recommend, administer or arrange for the prescribing, administration, purchasing, sale or formulary placement of any Camurus product or to reward any past such behavior.
All ISS support is provided with the understanding that it is public and transparent and will be disclosed and publicly declared. All support by Camurus should be clearly acknowledged by the recipient and the study should be filed with appropriate public clinical trials databases when applicable. By accepting any ISS support, Camurus and the recipient must warrant that they shall comply with all applicable laws, regulations, industry code and guidelines (including but not limited to the European Federation of Pharmaceutical Industries and Associations [EFPIA] code of practice).
The application should be accompanied by a concept sheet containing key information about the ISS, further instructions on the next page.
If failing to comply with the above, your request cannot be considered for review.
Investigators will receive notification that their study proposal has been received and scheduled for review.
If a proposal is approved, an agreement process will be initiated, and ISS support will be provided according to agreed schedule once agreement has been mutually agreed and fully executed.
Following the completion of the study, Camurus should receive a clinical study report within six months.
Information about how Camurus processes personal data can be found at privacy notice.
Welcome to contact Camurus at ISS@camurus.com should you have any questions whilst compiling your request or during the review process.