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You want fast subject recruitment, compliant site performance and reliable data. You need efficient trial monitoring and well prepared clinical trial sites.

Monitors are the backbone of your clinical trial. Ethicare monitors:

  •  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

Monitoring is a major cost factor in your clinical trial budget. Investing the money in an efficient monitoring service that considers the priority and complexity of your project without compromising quality is crucial for success. Ethicare helps you to find the right solutions and offers much more for your clinical trial, including:

  •  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/li>
  •  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:

  •  Appropriate training
  •  The scientific and medical knowledge to monitor your trial
  •  Documented evidence of their educational background, their specific qualifications and their extensive experiences

All Ethicare clinical monitors have received training in GCP, local laws, safety reporting requirements and other relevant areas of their daily work.

Building relationships with investigators and site personnel is another important key to your trial’s success. The <>Ethicare clinical monitor is trained to significantly influence the site performance (e.g. recruitment, data quality, protocol compliance etc.). Ethicare clinical monitors are dedicated to your clinical trials and will assure constant quality and performance.

Monitoring Concept

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.

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 can perform site visits at one or more sites to identify causes and find timely solutions. We will conduct a detailed and professional root cause analysis and together with the site team, agree on individual solutions. We will work hard to ensure clinical trial sites pay adequate and proper attention to your trial.

Ethicare will follow up on solution agreements and maintain a high level of motivation at each site. Sometimes small adjustments and innovative ideas are the best solutions.