Information to Clinical Trial Sponsors

A clinical trial is a study done in human subjects to investigate a potential new drug, device or biologic product. A clinical trial sponsor is an individual, institution, company or organization that takes the responsibility to initiate, manage or finance the clinical trial.

The purpose of Clinical Trial is to ensure that the treatment is safe in humans, and to determine how and where it distributes within the body. This testing normally takes place with a small group of healthy volunteers. The trial sponsor monitors for potential “serious adverse events”— that is, any toxic, undesirable, or unwanted effect that causes death or danger to health, like a disability or permanent damage, birth defect, heart attack, or other serious medical condition.

A sponsor can transfer any or all of its trial-related duties to a contract research organization or CRO, but the ultimate responsibility for the quality and integrity of trial data always resides with the sponsor.

Sponsors’ responsibilities

• Select Investigators
• Monitor progress of clinical trial
• Ensure trial is conducted in accordance with protocol
• Monitor safety
• Drug disposition and reconciliation
• Maintain required records and reports
• Transfer of obligations to a CRO

The information presented in these articles is intended to outline the general processes, principles and concepts of the healthcare product development lifecycle. Since regulatory requirements are ever-changing, it is current only as of the date of publication and not intended to provide detailed instructions for product development. Every healthcare product is unique and therefore so is its associated product development lifecycle. Specific advice should be sought from a qualified healthcare or other appropriate professional.