Investigator Sponsored Research
BeiGene is committed to patient-focused and scientifically driven research as we discover and develop new therapies in our unserved local market and the rest of the world.
BeiGene’s Investigator Sponsored Research (ISR) program supports research, including non-clinical, clinical, health economics and outcomes research (HEOR), and non-interventional studies (real world evidence).
Investigator Sponsored Research (ISR) is a study initiated and conducted by a qualified research investigator or sponsor, alone or in collaboration with others, and provides immediate direction related to the administration, dispensing, and appropriate use of drugs for research.
An ISR investigator/sponsor is responsible for completing the ISR concept submission, providing all required ISR related supporting documents, monitoring and overseeing the study in conformance with the ICH Guidelines and GCPs, and complying with the provisions of the executed BeiGene ISR agreement. The independence of the ISR investigator/sponsor must be maintained for the design and conduct of an ISR study.
ISR submissions are reviewed by BeiGene’s interdisciplinary Internal Review Committee (IRC). Decisions are based upon scientific merit of the proposal to address legitimate medical and scientific questions, alignment with the company’s research and development plans and defined areas of strategic research interest, protection of the safety of patients in terms of dosing, dosing schedule and potential interactions of approved or novel drugs in combination studies, as well as availability of resources. Support of a study does not imply any obligation toward or connection to the recommendation, referring or prescribing of BeiGene products.