ROLE OF SITE MANAGEMENT ORGANIZATION FOR CONDUCTING TRIALS IN INDIA

India promises to be one of the hottest destinations for conducting global clinical research owing to a large number of hospitals, experienced doctors, huge patient pool representing both chronic and infectious diseases, easy recruitment of patients, and high cost savings. But even now India shares only a small market of clinical research when compared to the current global opportunity. As India is becoming a promising destination for many pharma and biotech based company, it is expected that the clinical trials conducted in India also will grow to several folds. The main attraction of global pharma companies to start their function in India is reduced cost to conduct clinical trials, when compared to the other part of the world. So to attract more companies to conduct trials in India we should also take in to consideration of conducting clinical trials in a cost effective manner. Here comes the important of Site Management Organization (SMO) for conducting clinical trials in India. It has been already proven that this will decrease the costs of conducting trials when compared to other modes for conducting the trial.

The main services of a SMO include site feasibility study, project feasibility study in a particular region, Investigator identification, patient recruitment, site monitoring, documentation, IEC etc. SMOs can act as service providers for both pharma companies and CRO’s. SMOs will help in reducing the time taken for patient recruitment, which is the main task for starting a clinical trial and also will make the communication easy with the sites and sponsors. This is possible because of the good contact of SMOs with the regional hospitals and investigators which the pharma companies and CROs lack. We all know that now a days investigator are stuck in their own busy schedule, and so investigators shows less interest to conduct trials or they are unable to concentrate on clinical trials. Here comes the important of SMO who can also act as a service provider to hospitals and investigators apart from pharma companies. The main task in conducting a clinical trial in a site includes patient identification and recruitment.SMO helps in recruitment of patients according to inclusion & exclusion criteria as described in the study protocol and ensures that the enrolled study subjects are informed about their schedule of visits well in advance and that they do not miss their visits. They also can undertake all documentation works, maintain log books, maintain the drugs according the protocol, submission of reports to IEC etc .Thus the investigator can take care of the patient care only and this will reduce the burden over the investigators and also reduces time and costs for the sponsors.

For a multicentre trial the sponsor has to recognize many sites and investigators with all required facilities and experiences. This will be much easier for a SMO with good regional contacts when compared to multinational pharma companies and CROs.SMO can conduct the site feasibility and will be able to conduct the trial with dedicated investigators and staffs in a much easier way than a pharma company which directly conducts the trials at a site. The amount spend by the sponsor organization for conducting site monitoring, site feasibility study, patient recruitment and documentation is very high which can be clearly reduced by outsourcing the above tasks to a SMO at that particular region.

According to Mr.Prathap Vasu.C, Chief of Business Solutions, Leads Clinical Research, a SMO based at Bangalore, India “The benefits of outsourcing a trial to SMO are rapid patient recruitment, accurate and consistent documentation, reduced study timelines due to quicker study start-up, more accurate doctor contact information, reduced site management time, improved relationships with investigators and cost effective”.

A SMO with good contact with hospitals with GCP trained investigators, good patient population and CRC's & Project Managers with proper training is a good option for pharma companies for conducting trials in a .cost effective manner.