Investigator-Initiated Trials (IIT) have seen substantial growth, particularly in drug and medical device research. IITs are initiated by investigators addressing clinical needs without focus on product registration or marketing, thereby offering flexibility for advancing clinical practices, especially for GCT (gene and cell therapy) product.

Similar to an investigator, the sponsor’s role is the same on an IIT as it would be on an industry-sponsored trial. The sponsor is the entity initiating the clinical trial and acting as the coordinating center. They select qualified investigators at other sites they believe are a good fit for the trial.

A sponsor’s responsibilities include:

• Select qualified investigators
• Manufacture the qualified drug product
• Assure the protection of human subjects
• Provide the investigator with information to conduct the investigation properly
• Monitor progress of investigation
• Control and document disposition of investigational product

Typically, IIT demonstrate collaboration, institutional commitment, and organizational capabilities and involve frequent cross-functional collaboration. Nikebio have experienced experts in different areas such as Process Development/Assay development and manufacture, Preclinical and Clinical resources to one-stop solution service for IIT clinical.