Monitoring

SFS fully understands that sponsors have different experience and comfort due to the monitoring strategy. Our flexible approach allows SFS and our clients to identify the best study-specific monitoring strategy that aligns with the study-specific risks identified. A variety of factors can influence to the final monitoring strategy, including:

  • Study Phase and Design
  • Clinical objectives
  • Safety profile of product/device
  • Kind of treatment and standard of care
  • Complexity of study-specific requirements
  • Number of sites/patients
  • Site profile (i.e., research naïve)
  • Study duration (patient retention requirements)

We grant
the alignment of the study and clinical practices with the international standards.

We help
the site, PI or designed team to prepare information to be entered into the eCRF.

We prepare
investigator meeting, presentation and clinical trial documentation.

We manage
the investigator payment, queries, patient´s safety, drug accountability.

We monitor
the sites and patient recruitment to assure the protocol alignment.