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FARMOVS Site Management Organisation Division

Extend your reach to the right clinical trial participants

FARMOVS supports clinical research in different patient populations in partnership with external sites via the SMO division. Through these partnerships, we work in close collaboration with medical doctors, specialist physicians, hospitals as well as dedicated research centres, across all therapeutic areas.

The SMO division provides project management and clinical trial monitoring services to our clients. The project management services include oversight of the clinical execution and clinical trial monitoring as well as the oversight of other wrap around services such as Medical Monitoring, Data Management and Statistics, Central (Safety and PK) Laboratory Management, Pharmaceutical Deport Services as well as Regulatory services.

FARMOVS SMO can also easily adapt the full-service model by providing only Project Management or Monitoring as separate standalone services lines.

 

The FARMOVS SMO Division Services Include:

Project Management:

The FARMOVS SMO management will assign a clinical study manager (CSM) to a project based on the level of experience required and complexity of the project. The clinical study manager owns the client relationship and is responsible for client communication, ensuring high client satisfaction. The CSM will ensure ongoing communication to team members of the scope of work, timelines and project goals, technical information, and input from client throughout the project.

The CSM undertakes the full range of duties relevant to managing clinical trials to ensure that their performance meets and/or exceeds client expectations, including monitoring project progress according to agreed timelines and within budget constraints.

Feasibility and site selection in collaboration with the sponsor and appointed monitors are performed.The CSM will ensure compliance to the project specific study plans and monitoring plans.

All CSM activities and oversight responsibilities are clearly defined and described in a dedicated set of controlled document templates and Standard Operating Procedures (SOPs).  On a project level a Project Management Plan dictates the project specific management model in collaboration with the contracted Roles and Responsibilities.

 

Clinical Trial Monitoring:

The FARMOVS SMO has access to a network of experienced monitors/clinical research associates who work closely with the FARMOVS SMO CSMs on a clinical trial.  The SMO will appoint, manage and oversee these monitors/CRAs who performs study monitoring functions at the selected investigators sites, reporting to the FARMOVS CSM, according to FARMOVS SMO SOPs.  The monitor will be the contact between the investigator and the CSM who will be responsible for sponsor communication.

As per ICH GCP 5.18.1 the purpose of trial monitoring is to verify:

    • The rights and well-being of human subjects are protected
    • The reported trial data are accurate, complete and verifiable from source data
    • The conduct of the trial complies with the current approved protocol/amendments, GCP and with the applicable regulatory requirements.

The monitor performs on site visits at the investigator site to verify these aspects.

For clinical trials where the sponsor appoints the trial monitor, the monitor will report on the above aspects directly to the sponsor, but will work closely with the FARMOVS SMO CSM who oversees the trial.

 

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