This is Glenmark’s dedicated page for Investigator Initiated Trials (IITs) involving Glenmark’s products and its related therapeutic areas. We believe in nurturing collaboration with Investigators to advance scientific knowledge and explore new therapeutic possibilities. Please see the information about Glenmark’s commitment to supporting IITs and how you can engage with us in this endeavor. About Investigator Initiated Trials (IITs) Investigator Initiated Trials (IITs) are clinical studies of scientific and medical merit conducted by independent researchers to investigate safety, efficacy and potential new uses of pharmaceutical products. In such studies, investigator is the study sponsor. These trials are initiated, designed and conducted by investigators or institutions with the support of pharmaceutical companies such as Glenmark. Glenmark’s Commitment to IITs At Glenmark, we recognize the crucial role of IITs in expanding medical research and improving patient health. We are committed to supporting investigators who propose well-designed studies that align with our therapeutic areas of interest. What is in-scope

1. Interventional studies
2. Non-interventional studies such as prospective observational, retrospective data reviews, meta-analyses, registries, outcomes research, and epidemiology studies.
3. Human biological sample studies involving primary cells or other materials such as plasma, serum, urine etc.
4. Non-clinical studies including animal model studies or in vitro assays

What is out-of-scope

1. Any study that is a post-authorization requirement, commitment to a health authority (HA), or intended for HA submission
2. Market research including surveys for market research
3. Patient Support Program
4. Database reanalysis e.g., post-hoc analysis of Glenmark data or reanalysis of a study that had been previously supported as an IIT

Collaboration Opportunities Glenmark welcomes proposals from investigators who are interested in conducting IITs involving Glenmark products or related therapeutic areas. Collaborative projects may receive financial support, drug supply or both, or other support such as diagnostic tests, CRO support depending on the nature and scope of the study provided that they align with Glenmark’s defined areas of strategic interest. Our goal is to facilitate high-quality research that contributes to the scientific community and ultimately benefits patient. How to submit proposal: If you are a researcher interested in conducting an IIT involving Glenmark products or related therapeutic area, then please click on the link below to submit your proposal. Each submission will be reviewed by the Global Medical Affairs team of Glenmark based on scientific merit, and alignment with corporate research, key business objectives and development plans. The requestor will be informed about the outcome and in case Glenmark is interested in the proposal, the requestor will be contacted and invited to submit further details and a final protocol on the IIT. The following documents will be required by Glenmark to be in place before support can be initiated-

1. Fully executed IIT agreement between Glenmark and Investigator
2. Independent Ethics Committee/Institutional Review Board and/or health authority approval letter

All funding requests will be assessed to ensure that they do not exceed local fair market value. Funding requests for expenses not associated with the conduct of the study are strictly prohibited. Submit IIT proposal