Site Management Organization

Site Management Organization

Bringing Clinical Trial Closer to
the Sites and Patients

A success on clinical trial conduct requires a good site management system. By doing so, the site team might be able to perform clinical trial activities effectively and efficiently whilst ensure the compliance to protocol, Good Clinical Practice guideline and other applicable regulations. At the end, it ensures data integrity and protections of human subjects that involved in clinical trial.

Site Management Organization (SMO) division in Prodia that has been initiated since 2014 aimed to improve the clinical trial awareness and strengthen the capacity of the trial sites in Indonesia.


SMO also provides integrated service in supporting clinical trials including feasibility study to identify strategies to mitigate the costs and risks associated with the proposed trials, site and investigator selection to assess and select the sites and investigators to site suitability on the proposed trials, ensure site and investigator compliance with the protocol, ICH-GCP, all applicable regulations and time constraints.

Site Management Organization also provides support to the site such as providing committed and qualified study staff to ensure day to day conduct of clinical trial according to GCP, providing trainings for all study personnel, providing subjects recruitment service to ensure site can meet the target subject and timeline, and also performing trial site capacity building through Clinical Research Unit Development.

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