Monitoring

Our dedicated team of clinical trial monitors help ensure the quality and compliance of your clinical trial. Through regular monitoring visits, data verification, and oversight, we safeguard adherence to protocols, regulations, and ethical standards. We thereby uphold the safety of participants and data integrity throughout the study.

We offer on-site and remote monitoring, and central data monitoring.

Our Services


Monitoring Types:

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On-site Monitoring

  Our on-site monitoring includes regular visits to trial sites. During these visits, the monitor reviews source documents, case report forms (CRFs), and other trial-related records to ensure accuracy and completeness.


We independently review adherence to the protocol, Standard Operating Procedures, Good Clinical Practice guidelines, and regulatory requirements. Additionally, monitors provide ongoing support to the trial teams on site, addressing any questions that may arise.

 

Remote Monitoring

 Remote Monitoring entails clinical monitors reviewing trial-related processes remotely rather than being physically present at the study site. This includes ensuring proper documentation of the informed consent procedure, timely reporting of adverse events, adherence to study interventions and timelines, and maintaining all required documentation.


Additionally, it involves reviewing training records and confirming the authorization and qualifications of the study team by the principal investigator.

 

Central Data Monitoring

 Central Data Monitoring involves the remote review and analysis of accumulated study data to detect inconsistencies and potential issues, thereby improving data quality and ensuring completeness. It is typically performed continuously throughout the study and includes range, plausibility, and consistency checks.

 

The Monitoring division often collaborates closely with the Statistics and Methodology division, where statisticians provide reports on data issues that are then followed up by the monitors. In the context of risk-based monitoring, findings identified during central data monitoring may trigger on-site visits.
 

Do you want to know more about the potential benefits of centralized data checks for your study?


Monitoring Activities:

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Monitoring Planning
  • While it is at the sponsor's discretion to determine the extent and frequency of monitoring, we provide guidance based on your protocol and CRFs to help inform your decision regarding the level of study monitoring.
  • Our team crafts a customized monitoring plan that delineates the details of the monitoring process, encompassing the frequency and depth of on-site visits and data verification.
  • In cases where central data monitoring is implemented, a central data monitoring plan outlines the scope of central data monitoring and specifies the types of checks to be conducted. This plan is developed collaboratively by the central data monitor, the sponsor or delegate, and the statistician.  

Pre-study Visit
  • We conduct Pre-Study Visits on behalf of the sponsor, where a monitor assesses the suitability of a site for participation in the planned clinical trial. These visits entail facility inspections, and discussions with site personnel regarding the key aspects of the planned study.

Site Initiation Visit
  • This visit is essential for preparing the study center before the study conduct starts. During this visit, we review the necessary preparations to ensure the site is ready to initiate study conduct. We provide introduction and training to GCP and study requirements and procedures.
  • Various aspects such as protocol and visit plans, informed consent processes, adverse event reporting, and investigational product handling are covered.
  • As agreed, we obtain essential documents from the study site on the sponsors' behalf. These visits also offer an opportunity for the site to address any questions or concerns, ensuring a comprehensive understanding before the study begins.

On-site Monitoring Visits
  • Throughout the study, we conduct on-site monitoring visits according to the monitoring plan. These monitoring activities include reviewing the study progress, ensuring adherence to the protocol and regulatory requirements, verifying entries in the case report forms (CRF) against the original source data (e.g., medical records), conducting trainings, overseeing drug accountability, and addressing any emerging issues.
  • Following each site visit, our monitor communicates relevant findings to both the sponsor and the site in writing and may create a list of outstanding tasks that could not be resolved during the visit and need to be further addressed.

Central Data Monitoring
  • Our central data monitoring services involve the remote review and analysis of accumulated study data to detect inconsistencies and potential issues, thereby improving data quality and ensuring completeness. It is typically performed continuously throughout the study and includes range, plausibility, and consistency checks.
  • The Monitoring division often collaborates closely with the Statistics and Methodology division, where statisticians provide reports on data issues that are then followed up by the monitors. In the context of risk-based monitoring, findings identified during central data monitoring may trigger on-site visits.

Close-Out Visit and Final Report
  • As the study concludes at a site, we conduct a comprehensive close-out visit to confirm the formal end of the trial. Together with the study team, we finalize study documents, ensure the completeness of study files, and ensure study drug accountability (if applicable).
  • Additionally, we address any outstanding issues and help resolve open queries as needed to ensure a smooth conclusion of the study at the site

Benefits of Centralized Data Checks

  • Monitor recruitment rates to oversee the progress of the study and identify poorly performing study sites
  • Perform range checks of pre-specified data points, e.g., if a lab value is within a certain range (if not already implemented in the electronic case report form see Data Management)
  • Perform plausibility checks, including comparisons of the same measure across time; ensure consistency across data points, such as checking that pregnancy is only recorded for female participants (if not already implemented in the electronic case report form, see Data Management)
  • Assess the distribution of numeric data within and across study sites to identify outlying data points (resulting in queries to confirm or correct a value) or outlying centers (which could indicate differences in analytical methods)
  • Employ statistical techniques to identify possible data fabrication, which will trigger on-site monitoring visits

Result of these checks? Most checks will result in individual queries to a study site, but others might trigger on-site monitoring visits or direct contact between the study sponsor and the study site.