Large number of hospitals, well qualified and experienced doctors, very huge patient pool emblematizing chronic as well as infectious diseases, high cost saving and easy patient recruitment is leading India to become a lucrative hub for conducting global clinical trials. The reduced cost of conducting clinical trials in India as compared to other parts of the world, is serving as the main attraction point for many global pharmaceutical and biotechnology companies to start their operations in India.
In order to attract more pharmaceutical companies to outsource their clinical trials in India, the importance of Site management Organization (SMO) comes into picture. SMO’s are relatively new conferee aiming at providing economical conduct of clinical trials. As the name ‘site management organization’ itself states, it is an organization that specializes in managing clinical research sites. SMO’s usually have a network of clinical research sites which they manage and work with dedicatedly… SMO’s may manage all or a part of clinical research activity at a clinical research site based on their understanding and agreement with the head of the clinical research site, which may be a hospital or a private practice.
SMO’s are service providers for Contract Research Organizations (CRO’s), pharmaceutical companies, biotechnology companies, medical device companies and even clinical research sites. This budding SMO industry is currently reckoned at about $3 billion and is expected to grow further as per the recent estimates from R&D Directions – a market research firm. Some of the services offered by the SMO include project feasibility, investigator selection, submission of documents for Institutional Review Board or Independent Ethics Committee (IRB/IEC) approval, patient counseling, patient recruitment, patient follow-up, informed consent form (ICF) translation into vernacular languages etc.
The time taken for patient recruitment is considerably reduced by using site management organizations and patient compliance throughout the study is also better due to effective follow up by SMO staff deployed at clinical research sites. These objectives are achieved by the good contacts of the SMO with the regional hospitals and investigators which the pharmaceutical companies and some CROs lack.
SMO also perpetrate as a service provider for investigators and hospitals. Patient identification and recruitment are the main tasks involved at the site. SMO helps in recruiting patients as per the study protocol, ensuring the study subjects are informed about the study procedures, visit schedules, laboratory procedures etc. SMO also helps the site with all documentation related work such as keeping the site files up to date at all times, maintaining study specific logs such as temperature log, drug accountability log etc, patient’s diaries, storing the drugs according to the protocol, submission of documents to ethics committee etc. Use of a SMO can also help the investigator concentrate on the patient recruitment, reducing the burden of the investigator and cost & time of the sponsor.
SMO can be a cost and time savers for the sponsor companies and CRO’s for initiating a multicentric clinical trials. As per 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”.
In the end I would just like to conclude that outsourcing a clinical trial to an SMO can be a real help to the global Pharmaceutical industry in terms of setting up their business in India as well as worldwide, since SMO will minimize their workload in an effective and efficient manner. Clinexa Life Sciences, a contract research organization has a large network of clinical trial sites and can provide effective site management solutions in India as well.