18/08/2025
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.
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.
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.
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
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.
Maintaining the right balance in monitoring strategies while ensuring high data quality, patients’ safety and compliance to protocol and regulations is crucial.
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.
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.
GCP-Service International: Your full-service Contract Research Organization (CRO) for phase I-IV clinical research with drugs, medical devices and in vitro diagnostic.
rpulles@gcp-service.com
www.gcp-service.com
