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05-Apr-2021

How site management organization (SMO)Work?

An SMO receives its income from a clinical trial fee related to the completion of a specific patient visit. Thus, the balance between income and costs can be very delicate with fewer studies or less patient recruitment. The whole success of an SMO is solely based on the first-hand knowledge of the patient population and well-defined relationships with investigator networks, enabling them to deliver and add value to the organization. More importantly, for a sponsor, this value is added to another line of the cash flow to that of a clinical research organization.

 An SMO works with the same line or network of investigators, clear benefits in terms of quality of data and consistency can be achieved. SMO have their independent standards of working along with independent work protocols and procedures, which put their investigators through common or generic clinical research training accompanied by some of the best clinical research courses. It can be seen that the SMO provides a common umbrella over its entire network of investigators reducing management or administrative support that a sponsor would need to provide to each site.

SMOs generally perpetrate as service providers for investigators and hospitals.  Patient recruitment and identification are the main tasks that are involved at any trial site. SMO recruits patients through the protocols while ensuring that the study subjects are well aware of the trial procedure. They also keep the trial subjects informed about various aspects of the trial, including laboratory procedures, visit schedules, study procedures, etc. The SMO also manages all document-related work. The addition of an SMO to a CRO can also help the investigator concentrate on patient recruitment, thus, reducing the burden of the investigator along with the cost and time of the sponsor.

Despite there not being any significant changes in the time-to-market, SMOs offer sponsors a lifeline for better patient recruitment. They improve the recruitment rates and the attainment of aggressive milestone timelines. As SMOs work closely with the site that supports and manages, they must know the strengths and weaknesses of the clinical research trials. They should also be well placed to make thorough assessments of the subjects to determine their suitability for the study. The feasibility study is the key tool for precise project placement, and it can also offer opinion-leading specialists in the key markets.

Conclusion

SMOs specialize in running clinical research courses sites. Outsourcing a clinical research trial to an SMO can help global pharmaceutical companies, especially in setting up a business as an SMO, will minimize their workload effectively and efficiently.

How site management organization (SMO)Work?

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Last Updated: 06-Apr-2021