Harmony Biosciences supports Investigator Sponsored Studies (ISS) aimed at furthering the understanding of our products and that align with our areas of scientific interest. Such studies may advance disease-related knowledge, improve patient care, or explore unmet clinical needs.
These research studies are initiated and conducted by external investigators with the appropriate (or relevant) scientific background and experience to conduct an independent scientific investigation. Investigator Sponsored Studies may be, but are not limited to, interventional (clinical and non-clinical), observational (epidemiological or outcomes) or survey studies.
The external sponsor-investigator assumes responsibility for the legal and regulatory requirements of the trial and the conduct and management of the study as defined by applicable laws, regulations, and guidance documents (e.g. 21 CFR Part 312, Good Clinical Practice (GCP), International Conference on Harmonization (ICH), and Good Pharmacovigilance Practices (GVP)).
The study proposal, outline, and protocol must be designed and written by the investigator, independent of Harmony Biosciences’ influence.
The Harmony Investigator Sponsored Study submission process includes two phases:
Areas of Scientific Interest:
For any questions, please email grants@harmonybiosciences.com.
Harmony does not provide grants to individuals unless an individual is acting as a sponsor investigator of an Investigator Sponsored Study.
Any funding provided by Harmony will be in compliance with all applicable laws, rules, and regulations.