Investigator Initiated Studies
Investigator initiated clinical studies play an important role in answering important medical and scientific questions regarding medicines and related diseases. Dova embraces new and innovative disease-related research that will assist in advancing science and improving patient care. One avenue through which we support enhancing such knowledge is the Investigator Initiated Study program. Investigator Initiated Studies are clinical studies initiated and managed by the investigator or institution, who, as the sponsor, is responsible for the conduct and management of the study as defined by applicable laws and regulations. We meticulously consider all synopses submitted in the context of our medical objectives and based upon scientific merit and availability of resources. If approved by Dova’s Medical Affairs Committee, Dova may support Investigator Initiated Studies by supplying medicines, funding, materials, or a combination of such, as allowed under applicable laws and regulations. Support of a clinical research study in no way implies any obligation toward, or is any way connected to, the recommendation or prescribing of Dova medicines.
Non-clinical studies and access to investigational medicines through compassionate use or expanded access are not considered Investigator Initiated Studies.
Prior to Dova being able to provide any support, the following documents should be in place:
- Fully executed Investigator Initiated Study Agreement between the sponsor and Dova
- Fully executed Investigator Initiated Safety Data Exchange Agreement between Sponsor and Dova EC/IRB Approval
For questions or for more information, please contact us at email@example.com.