Clinision endeavor to maintain the highly ethical standards for clinical research. All the clinical studies reviewed by Institutional Review Board. The purpose of the policy is to describe the requirements needed to initiate the clinical studies which may be investigator initiated or sponsor initiated. Any use of investigational product outside a clinical study or unlicensed product must be in accordance with local laws and regulations governing programs.
A sponsor is an individual, company, institution, or organization that takes responsibility to initiate, manage or finance the clinical trial, but does not actually conduct the investigation. Clinical research undertaken through sponsors are based on the need to address meaningful scientific and/or clinical objectives supported by valid scientific designs while respecting the privacy rights, safety and welfare of patients.
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Investigator initiated studies (IITs) are clinical studies initiated and managed by a non-pharmaceutical company researchers, like individual investigators, institutions, collaborative study groups or cooperative groups. The researcher is responsible for the legal and regulatory responsibilities of the trial sponsor for the conduct and management of the study as defined by all applicable laws and regulations.
