Investigator Initiated Trials

As part of our commitment to delivering innovative therapies to patients worldwide, Synergy believes in supporting ethical independent clinical research conducted by qualified third party investigators. The value of the scientific research that is produced by such investigators is key to complementing Synergy sponsored research in helping ensure we better understand the benefit/risk profile of our therapies as well as explore new opportunities to address unmet medical needs. Such clinical research must set out to address meaningful scientific and/or clinical objectives supported by valid study designs in which the privacy rights, safety, and welfare of patients is of paramount importance.

Synergy provides financial support and/or drug product for IITs pursuant to a written agreement, which requires that third party sponsors comply with applicable local laws rules, guidelines and regulations. The overarching principles that govern the evaluation of IITs include:

  • The validity of the scientific question being addressed ensuring that any data generated by an IIT complement the existing body of evidence and not simply be a repetition of a previous study/experiment.
  • The robust nature of the IIT experiment/investigation being conducted in terms of ethical and design elements.
  • A commitment by the investigator/sponsor to disseminate the findings in an appropriate, transparent, and timely manner.

The IIT study is conducted independently of Synergy. The investigator or affiliated study sponsor has responsibility for study conception, design, operational execution, data handling, data analysis/interpretation, subsequent reporting/publication, and ensuring compliance with all local laws and regulations.

To submit an Investigator Initiated Trial, please submit your proposal to: investigatorinitiatedtrials@synergypharma.com.