Welcome to the Harmony Biosciences Investigator Sponsored Studies Submission Portal

Investigator Sponsored Studies (ISS) can play a role in exploring important medical and scientific questions regarding Harmony's products and our areas of scientific interest.  Such studies may advance disease-related knowledge and may contribute towards imporoved patient care.  

These research studies originate outside of Harmony and are designed and conducted by independent investigator with the relevant scientific background and experience to conduct a scientific investigation.  Investigator Sponsored Studies may be, but are not limited to, clinical, pre-clinical, epidemiology, screening/diagnostic, or survey studies.  

• 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, 21 CFR Subpart D, Good Clinical Practice (GCP), International Conference on Harmonization (ICH), and Good Pharmacovigilance Practices (GVP)). 
• Obtaining approval to conduct the study by a review board (Institutional Review Board, Institutional Ethics Committee, Institutional Animal Review Committee, etc.) as appropriate to the study 
• Safety reporting to Harmony and IRB/Health Authorities (HA), etc. as appropriate to the study 
• Repackaging of drug supply as appropriate to the study  
• Submission of study updates, study reports, and academic abstracts, posters, publications

The Harmony Investigator Sponsored Study submission process includes two phases:

• The first phase requires a requestor to submit their research concept. After a review has been completed by the Harmony research grants committee, the investigator will be notified of the decision.
• If the concept demonstrates scientific rigor and aligns with Harmony's areas of scientific interest, the requestor will be required to initiate the next phase by submitting a full protocol and detailed budget within 60 days of concept approval. The full protocol should include a defined plan for study methodology, data capture, analysis, adverse event reporting, and a plan for public dissemination of data. After committee review of the full protocol, the requestor will be notified of a final decision. 

Through this portal you will be able to submit your concepts and protocols, see your submission status, and provide updates on any approved studies. 

To submit a request, please first create an account and upload a current CV. If you already have an account, please log in to continue. 

For technical assistance with the portal, please contact Harmony’s portal provider, SteepRock Inc., by phone: 718-576-1406, M-F 9am-8pm ET or email: support@steeprockinc.com. Should you wish to contact Harmony for any program specific questions please email grants@harmonybiosciences.com. 

The submission portal is hosted by Harmony's platform vendor, Steeprock, Inc.