Clinical Operations Network
Amselstra├če 25
D-68307 Mannheim, Germany
(nearest airport is Frankfurt/Main)
Tel.: +49 (621) 789 7000
Fax: +49 (621) 789 7010

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Quality Assurance / Management

The reputation for excellence CONET has earned in the drug development industry over the last 14 years is based on our own high demands for quality.

Our quality assurance group plays an active role in each project to ensure regulatory and sponsor requirements are completely followed at all times. Regular internal reviews guarantee high quality standards for your clinical trial. All study procedures are subjected to continuous and strict quality control.

CONET Standard Operating Procedures (SOPs) are in compliance with ICH-GCP, the Declaration of Helsinki, the German Medicines Act, and other national laws. CONET employees as well as the team members of our partner CROs are trained intensively on Good Clinical Practice (GCP), applicable SOPs and protocol-specific materials prior to conducting clinical activities. All new staff members are trained on an individual basis as soon as they join CONET. Training on GCP and SOPs are performed on a regular basis for the entire staff. Therefore, we ensure that all procedures and processes are uniform, controlled and documented appropriately.

Our quality assurance group offers services on a standalone basis or as a full-service:
  • Internal quality assurance
  • External site, study or system audits (routine or for cause audits)
  • Guidance for the client towards optimization of quality assurance and controlling systems
  • SOP writing, review and update
  • Regulatory guidance and training on ICH/GCP
  • Preparation for audits and inspections
  • Project audits, e.g. investigator files audits, trial master file audits, clinical study report audits and regulatory submission audits
  • Post audit and inspection support - we implement corrective and preventive action plans (CAPA) and help to improve performance

Audit or inspection preparation

In recent years sponsors have been increasingly looking for support during critical situations in their studies. Today CONET is specialized in managing crisis intervention. Therefore CONET frequently helps sites prepare for audits or inspections. If another CRO managing your clinical trial does not provide the expected performance, CONET can be contracted for clinical trial rescue service.

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