Quality Management


Quality Management

Comprehensive, sensible quality management reinforces the validity of the collected data, thus supporting the principles stipulated in ICH-GCP (protection of trial subjects, recording of valid, current and detailed data as well as transparency and traceability of the study conduct).

According to ICH-GCP, the sponsor is responsible for establishing and maintaining quality assurance and quality control systems.

Appropriate SOPs guarantee that tasks are carried out in a standardised procedure and that the applicable regulations are duly observed. SOPs can be designed such that any verification always requires a second person, thus preventing mistakes due to a lack of knowledge or premature action.

Already while conducting a clinical trial, targeted and cost-efficient monitoring guarantees high quality standards in data collection. This measure ensures the correct conduct of the clinical trial, both from an ethical point of view and in compliance with the legal provisions stipulated in national laws. Patient safety is guaranteed through monitoring.

Another building block in quality management is performing audits, which on one hand serve to ensure the quality of the services, and on the other hand motivate all persons involved in a clinical trial to always do their best.

In addition, the sponsor is responsible for ensuring that the services provided meet the necessary quality standards by selecting the appropriate staff or vendors.

Regular further training and seminars also contribute to improving the quality of the services provided.

Take advantage of our expertise in all building blocks of quality management – don’t hesitate to ask us for advice on how to implement appropriate measures:

  • Preparing and revising SOPs
  • Monitoring
  • Support in selecting appropriate staff
  • Support in selecting appropriate vendors
  • Preparing for audits and inspections
  • Support in responding to audit and inspection reports (establishing CAPA plans)
  • Performing accompanyied site visits with CRAs
  • Extensive range of seminars

Quality Management

Comprehensive, sensible quality management reinforces the validity of the collected data, thus strengthening the credibility of your non-interventional study (NIS).

The trial sponsor is responsible for establishing and maintaining quality assurance and quality control systems.

Appropriate SOPs guarantee that tasks are carried out in a standardised procedure and that the applicable regulations are duly observed.

Already while conducting a NIS, targeted and cost-efficient monitoring guarantees high quality standards in data collection. This measure ensures the correct conduct of the trial, not only from an ethical point of view, but also in compliance with the regulations. Patient safety is guaranteed through monitoring.

Another building block in quality management is performing audits, which on one hand serve to ensure the quality of the services, and on the other hand motivate all persons involved in a clinical trial to always do their best.

Regular further training and seminars also contribute to improving the quality of the services provided.

The sponsor is responsible for ensuring that the services provided meet the necessary quality standards by selecting the appropriate staff or vendors.

Take advantage of our expertise in all building blocks of quality management – don’t hesitate to ask us for advice on how to implement appropriate measures:

  • Preparing and revising SOPs
  • Monitoring
  • Support in selecting appropriate staff
  • Support in selecting appropriate vendors
  • Preparing for audits and inspections
  • Support in responding to audit and inspection reports (establishing CAPA plans)
  • Performing accompanyied site visits with CRAs
  • Extensive range of seminar

Quality Management

Comprehensive, sensible quality management reinforces the validity of the collected data, thus supporting the principles that apply to clinical trials (protection of trial subjects, recording of valid, current and detailed data as well as transparency and traceability of the study conduct).

For medical devices, a certified quality management system (QM system) pursuant to DIN EN ISO 13485:2016 should be in place prior to applying for and obtaining the CE mark. Following the initial certification, repeat audits are carried out annually, and certification audits are performed at the latest after five years. A QM system is thus indispensable for maintaining the marketing authorisation.

According to DIN EN ISO 14155, appropriate SOPs must be in place to ensure that all recorded data are generated and documented in accordance with this standard, the CIP and all applicable regulations, and that clinical trials are planned and conducted in accordance with these provisions.

Already while conducting clinical trials, targeted and cost-efficient monitoring guarantees high quality standards in data collection. This measure ensures the correct conduct of the clinical trial, both from an ethical point of view and in compliance with the regulations. Monitoring guarantees the safety of the subjects and patients, and also of the users.

Another building block in quality management is performing audits, which on one hand serve to ensure the quality of the services, and on the other hand motivate all persons involved in a clinical trial to always do their best.

Regular further training and seminars also contribute to improving the quality of the services provided.

Take advantage of our expertise in all building blocks of quality management – don’t hesitate to ask us for advice on how to implement appropriate measures:

  • Preparing and revising SOPs
  • Setting up a quality management system
  • Monitoring
  • Support in selecting appropriate staff
  • Support in selecting appropriate vendors
  • Preparing for audits and inspections
  • Support in responding to audit and inspection reports (establishing CAPA plans)
  • Performing accompanyied site visits with CRAs