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Clinical Monitoring

Unparalleled monitoring performance across all phases and therapeutic areas

 

Wide Range of Clinical Monitoring Services Throughout Phases I-IV

Our Services Include:

  • Feasibility process & Site selection
  • Analysis of competitive studies and site workload
  • Pre-study site evaluation visits
  • Set up of investigational sites
  • Investigator meetings (preparation, travel arrangements, conduct)
  • Study initiation
  • Site monitoring
  • Site management between visits
  • Close-out visits and archiving

Recruitment Targets Were Reached or Exceeded Ahead of Time in 93% of Studies Within Our Care

Our clinical operation services are conducted across all therapeutic areas and phases. SanaClis actively utilizes comprehensive internal and external databases which contain sites participating or eligible to participate in clinical trials, based upon stringent study criteria. 

We have built and maintained long-term relationships with clinical investigation sites around the world over the last 25 years.

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Robust Reporting Structure

Our robust and comprehensive reporting structure continuously ensures that quality and study objectives are met. 

 

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Back-up CRA

Standby FTE CRA´s allocated to each  project in the event of workload peaks, illness, vacation (of study CRA) and all other eventualities. An approach which is safeguarded via our internal Resource Plan which forms part of the SanaClis Quality Manual.

 

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Supervising Manager 

Highly experienced in international studies with at least 10 years experience.
Provides local and immediate clinical and non-clinical support to ensure strict compliance with study timelines and objectives - including negotiations with authorities and institutions (customs, hospitals, regulatory).

 

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Local Quality Manager

Works in close cooperation with Supervising Manager to maintain quality across all fundamental areas.

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Quality Director 

Works in close cooperation with Supervising Manager to maintain quality across all fundamental areas.

Monitoring Strategies 

  • Classical on-site SDV
  • Risk-Based Monitoring
    with flexible SDV volume
  • Centralized Monitoring
  • Decentralized Monitoring options
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