Externally Sponsored Research

Externally Sponsored Research

The mission of the Externally Sponsored Research (ESR) Program at Mallinckrodt is to improve the lives of our patients by increasing the medical and scientific understanding of our products and related therapeutic areas. One way we can advance the knowledge base on diseases, disease management, and therapeutic outcomes is through support of independently initiated research.

This global program is open to all academic and community-based researchers who are interested in conducting their own research and fall into two categories of sponsor-investigator engagement:

• Investigator Initiated Research (IIR) – IIR studies (including, but not limited to clinical trials, registries, health outcomes studies or pre-clinical research studies) involving Mallinckrodt’s drugs and/or devices where a third-party Investigator proposes the study, acts as the Sponsor-Investigator and assumes all responsibility for the conduct of the study. Except in the case of US Government controlled cooperative research group IIR trials, Mallinckrodt may provide drug, device, and/or financial support. These studies can involve investigational or marketed products.
• Externally Collaborated Research (ECR) - Scientific research related arrangement with external investigators or research consortiums/networks involving Mallinckrodt drugs and/or devices. Mallinckrodt may provide financial support, device, and/or drug supply. Mallinckrodt works collaboratively with the external Investigator/Consortium on the protocol design, analysis, and publication of an ECR.

 As the sponsor of the study, the investigator and/or institution assume responsibility for all aspects of the study, including:

• Study design, concept submission, and protocol development (in an ECR, the protocol will be drafted by the investigator and collaborated on with MNK)
• Institutional and regulatory approvals and reporting requirements
• Study conduct in accordance with ICH GCP Guidelines and all applicable local and regulatory requirements
• Dissemination of study results in peer-reviewed publications

Mallinckrodt’s Grants Review Committee meets regularly to review all submissions and awards funding based on medical or scientific merit, unmet medical need, study feasibility, and availability of funds. Mallinckrodt may provide support for ESR studies in the form of funding, devices and/or study drug, depending upon the type of research.

Please submit all requests through our online portal by clicking here: Apply Now. If a concept is of interest, a request for full protocol submission will be issued.