Clinical Monitoring

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Clinical Monitoring

Ethicare Preforms robust monitoring to ensure site compliance, reliable data and fast recruitment. The Ethicare monitor’s first priority is acting as the main line of communication between the sponsor and the investigator. Considering this, it is obvious that the monitor significantly affects the investigator and site performance. The monitor’s knowledge and capabilities strongly influence the timeliness and reliability of data. Ethicare provides various types of Monitoring Services.

Late phase studies Monitoring
Early phase studies Monitoring
Risk-based Monitoring
Medical Monitoring
Central / Remote / Virtual Monitoring
Site Audit Support
Site Initiation Monitoring Visit
Interim Monitoring Visit
Site Close out Visit

Prospective of Monitoring

Protect the rights, safety and well-being of your clinical trial subjects
Oversee the progress of your clinical trial
Support fast recruitment
Ensure protocol compliance
Apply SOPs, GCP and applicable regulatory requirements
Ensure accurateness and reliability of clinical data
Help to increase acceptance of clinical data by the regulatory authorities
Feasibility studies and concepts
Assessments of sites and investigator qualifications
Training of investigators and their teams (e.g. GCP, safety reporting, IMP handling)
Ethics committee and regulatory authority submissions
Investigator Site File compilation and review
Translation of study-specific documents including quality check
GCP monitoring
Site management
Study logistics support
Support for site audits and inspections
Preparation of investigator meetings
State-of-the-art study / project management, including risk management
Intensive training sessions during investigator meetings (e.g. GCP, safety reporting, IMP handling)
Supporting analysis on data quality and timeliness as well as on individual investigational site performance

Ethicare Clinical Monitors

Ethicare is known for its highly qualified personnel. We continually invest in improving the skills and capabilities of our most important asset – our staff, which includes our clinical monitors. Ethicare clinical monitors have:

All Ethicare clinical monitors have received training in Expertise in GCP, local regulations, safety reporting requirements, and all relevant aspects of day-to-day clinical trial operations.Building relationships with investigators and site personnel is another important key to your trial’s success. Ethicare clinical monitors are highly trained professionals who actively enhance site performance in key areas such as patient recruitment, data quality, and protocol compliance. Dedicated exclusively to your clinical trial, they ensure consistent quality and reliable performance throughout the study.

Motivation concepts for sites

A variety of challenges can occur during the conduct of a clinical trial, such as:

Slow patient recruitment
Late data reporting
Informed consent problems
Reported data quality below expectations
High number of protocol deviations
Records not kept adequate and accurate

Ethicare performs site visits at one or more sites to identify causes and find timely solutions. We conduct detailed and professional root cause analysis and together with the site team, agree on individual solutions.