Managing clinical investigator compliance to ensure FDA inspection readiness

Medicilon is the first CRO company to provide a full set of pre-clinical trial services and our company meet chinese GLP a nd the USA GLP standards at the same time.Our company is the only one China CRO company to build cooperation with the foreign large CRO company.Medicilon provides biology, chemistry and preclinical research,our animal experiment facility has won international assessment of experimental animals and recognition(AAALAC) and chinese food and drug administration GLP certificate,and has reached the United States food and frug administration GLP standard.

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Adherence to the principles of good clinical practice (GCP), including adequate human subject protection (HSP) is universally recognized as a critical requirement to the conduct of clinical research. Compliance of a clinical investigator conducting a clinical trial is extremely important with regards to regulatory inspections on clinical investigators, sponsors, monitors, contract research organizations. In the U.S., the Food and Drug Administration (FDA) is an agency of the United States Department of Health and Human Services. The FDA is responsible for protecting and promoting public health through the regulation and supervision of food safety, tobacco products, dietary supplements, prescription and over-the-counter pharmaceutical drugs, vaccines, biopharmaceuticals, blood transfusions, medical devices, electromagnetic radiation emitting devices, veterinary products and cosmetics. As such, the FDA has oversight authority over clinical trials.

Compliance with federal regulations is the responsibility of the clinical investigator and the sponsor. A clinical investigator is usually referred to as the investigator in FDA regulations and guidelines. An investigator is a person who actually conducts a clinical investigation. The investigator is responsible for how the investigational product is administered and to whom the product is dispensed or used. In the event of an investigation being conducted by a team of individuals, the investigator refers to the responsible leader of that team. The clinical investigator is responsible for recruiting subjects, protecting the safety and welfare of subjects, supervising clinical studies using the investigational product, controlling accountability of investigational products and reporting the study results to the sponsor. A clinical investigator can delegate some of the tasks to the qualified personnel participating in trial but it is ultimately the responsibility of the clinical investigator to protect the safety of the subjects along with the integrity of trial.

A sponsor is a person or entity that initiates but does not actually conduct the investigation. An entity other than an individual (e.g., a corporation or an agency) which uses one or more of its employees to conduct an investigation that it has initiated is considered to be a sponsor. A contract research organization (CRO) also called a clinical research organization is a person or an organization (commercial, academic, or other) contracted by the sponsor to perform one or more of a sponsor’s trial related duties and functions. A monitor is an individual designated by a sponsor or contract research organization to oversee the progress of an investigation. The monitor may be an employee of a sponsor, or a consultant to the sponsor, or a representative from a CRO comapny.