Investigator Sponsored Studies (ISS) can play a significant role in exploring important medical and scientific questions regarding Harmony’s products and our areas of scientific focus. Such studies often advance disease-related knowledge and may contribute towards improved patient care.
These research studies are initiated, managed, and conducted by external investigators with the necessary scientific background and experience to conduct an independent scientific investigation. Investigator Sponsored Studies may be, but are not limited to, clinical, pre‑clinical, epidemiology, screening/diagnostic, or survey studies.
The 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 and regulations (e.g. 21 CFR 312.3, 21 CFR Subpart D, Good Clinical Practice (GCP), International Conference on Harmonization (ICH), and Good Pharmacovigilance Practices (GVP)).
To qualify for sponsorship, you must be a health care professional or researcher qualified by training and experience to undertake the proposed research. The study proposal, outline, and protocol must be originated 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 email@example.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.