Clinical Operations

Clinical Monitoring and Site Management

Effective clinical monitoring strategies should be flexible, dynamic and in accordance with ICH-GCP, Study Protocol as well as all applicable state and local regulations but choosing the right CRO that understands and is able to tailor fit smart solutions to every study is essential.

At GCP-Service, we understand clinical monitoring challenges especially those faced in modern clinical trials with focus on complex study design, study objectives, robust study data and have implemented solutions tailored to fit different studies to mitigate risks. Our Clinical monitoring team have extensive experience and will provide an added value to every study

“People working with people” - That´s our motto

Our Team 

We provide highly educated monitoring teams with Life-sciences background and monitoring experience of 30+ years’, overall study handle of 70+ Clinical Studies and strong therapeutic experiences ranging from Phase I-IV Pharmaceuticals and Medical Devices across all levels

To explore our Monitoring and Site Management solutions:

On-Site monitoring

Our goal is to provide the right balance for targeted Source Data Verification while ensuring high data quality and integrity, in compliance with Trial requirements, SOP’s and all regulatory requirements.

Our flexible and targeted on-site monitoring approach is uniquely fit to every study, accompanied with high emphasis on effective site communications and relationship building.

  • Our CRAs expertise and support through all stages of clinical development
  • Feasibility & Site Selection
  • Site qualification & initiation
  • Patients’ recruitment
  • Study Materials Creation and review
  • Essential documents collection and completion
  • Site and study specific trainings
  • Monitoring Visits reports
  • Site Inspection & audits preparation
  • Site monitoring & Close-Out visits

Remote monitoring

Keeping an oversight of Clinical Data remotely while ensuring patient safety and high data quality has been leveraged by our intelligent monitoring approach that provide a flexible, cost effective and in depth understanding of data to maintain trial oversight. 

Why Remote Clinical Data Monitoring?

Our agile approach ensures highest data quality and integrity in several ways

• Randomisation data review
• Active phases Data accuracy and completion compliance
• Data trends/Patterns comparison across study sites, subjects, or countries
• Medical codability and logic
• Proactive follow up of issues until resolution
• Statistical monitoring Outlier’s comparison with EDC data
• Realtime Data review across e-data sources
• Escalation of study data completion delays
• Speedy Data base lock

Centralised Statistical monitoring

Our team understands the Science of Data. By combining analytical figures and visualizations to identify poorly performing sites or subjects, we are able to detect suspicious patterns in clinical data across all patients, sites, or countries. This allows us predict areas of risks and mitigate solutions to prevent issues that may occur. The implementation of statistical monitoring processes to target onsite monitoring and SDV is a scientific method which can improve the quality of study data significantly while saving costs.

Hybrid monitoring

Our mission is to tailor fit to your study, finding the right balance for all our monitoring solutions: Centralised and On-site monitoring, to maintain the highest Quality and Integrity of Data.

Why you need the right balance

Maintaining the right balance in monitoring strategies while ensuring high data quality, patients’ safety and compliance to protocol and regulations is crucial.

  • Maintaining the right balance in monitoring strategies while ensuring high data quality, patients’ safety and compliance to protocol and regulations is crucial.
  • Over the years clinical monitoring has faced several challenges and has highlighted the need to adapt to the new complexities faced in modern clinical trials.
  • Our Quality management systems incorporated with Risk-based management enable us to provide effective and efficient monitoring methods by shifting resources to a targeted SDV accordingly.
  • We will support you by finding the right combination of our monitoring services to deliver quality data for your clinical trial. 

Over the years clinical monitoring has faced several challenges and has highlighted the need to adapt to the new complexities faced in modern clinical trials.


  • Our Quality management systems incorporated with Risk-based management enable us to provide effective and efficient monitoring methods by shifting resources to a targeted SDV accordingly.


We will support you by finding the right combination of our monitoring services to deliver quality data for your clinical trial.