As PI holds all the responsibility of the clinical trial he is supposed to do each and everything for the safety and efficacy of the Patient. PI is also responsible for reporting of every adverse reaction or event to the sponsor and to the Ethics Committee. However there are so many helping hands to assist the PI for the same.

Patient will be randomised or enrolled into the study on his own will for which the PI has to take the inform consent of these patients. These patient are the usual patient which you usually seen in your daily routine practice but they will be segreggated on the basis of the criteria mentioned in the protocol for the purpose of the study. These criteria are well known as inclusion and exclusion criteria.

However safety parameters are evaluated on every aspect of the trial so adverse effects are already anticipated. The protocol contains all the list of the anticipated adverse effect, if how ever any unanticipated adverse effect takes place then PI has to report the effect as soon as possible to the sponsor and ethics committee. The insurance is provided by the sponsor towards the patient in most of the trial.

However safety parameters are evaluated on every aspect of the trial so adverse effects are already anticipated. The protocol contains all the list of the anticipated adverse effect, if how ever any unanticipated adverse effect takes place then PI has to report the effect as soon as possible to the sponsor and ethics committee. The insurance is provided by the sponsor towards the patient in most of the trial.

Clinical trial is performed accordance with the Protocol,SOP (Standard Operating Procedures) ICH-GCP regualtion and regulation of local applicable regulatory authority. Clinical Trial is different from the regular clinical practice as clinical research requires documentation of each and every procedures in accordance with the regulatory requirement and protocol. For doing all these activities there is emergence of Site Management Organisation (SMO).

Site Management Organisation or Site Fascilitating Organisation is the Organisation which provides support in depth to the conduct of the clinical trial to the Principal Investigator. The Scope of the support extends from Site Assimilation, Resource management, Assist regulatory department in obtaining the approval, communication with the sponsor on behalf of PI, helps in finalising the budget to the PI for the conduct of the clinical trial, Providing the full manpower who are qualified in clinical research as Research Coordinator.

Clinical Research Coordinator is the person who coordinates with the principal investigator for the filing of the documents, case report forms, reporting of the Seriours Adverse Events to Ethics committee and maintenance of the regulatory binder. Anybody qulaified in clinical research and having graduation from biology stream can become CRC.

Clinical research coordinator from the Site management organisation will help you in proper execution of the trial.

PI is paid by the sponsor company a huge amount for conducting the clinical trial, this amount is usually many times graeter than the amount a Doctor charges from every patient in OPD and in any medical procedures.This amount is usually high so that the PI can concentrate well on study subjects as they receives the new molecule for the first time.However conducting the trial will enhance your career as it will give you international recognition and you will be the first to use the drug which has to come in the market in near future.

CaSFO is the site Fascilitating organisation providing all types of services related to the clinical research. And also helps in completing the clinical trial within time by providing assistance prompt competition of the documentation and helps in speedy patient recruitment and retention.