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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Safety and Medical Affairs

Patient safety is of utmost importance in every clinical trial. The CONET safety team works in close collaboration with our clinical trial management and regulatory team to maintain an overall view of your project and ensure that safety is managed effectively and within timelines.

CONET CRAs assure strict adherence with the reporting guidelines for adverse events and serious adverse events at anytime. They support investigators in detecting and documenting adverse events and stay in close contact with the sites to obtain the required information and to perform data reconciliation. All AEs and SAEs are followed up and reported timely, as our CRAs recognize the importance of identifying and evaluating risks during clinical trials.

CONET Safety and Medical Affairs services include continuous SAE processing and accurate reporting to all appropriate regulatory authorities, Ethics Committees, the sponsor and investigators in the required format and within the obliged timeframe.

From the beginning and during the course of the study CONET offers the following service:
  • Development of project-specific AE/SAE-specific handling and reporting guidelines
  • Drug-safety-specific training and support for investigators and study personnel
  • Medical monitor activities including 24-hour medical monitoring
  • Adverse Event and Serious Adverse Event Management and Reporting
    • Accurate review, documentation and collection of AE/SAEs in case report forms from clinical trials, triage/evaluation, follow-up and timely reporting to sponsor
    • Medical review and assessment of seriousness and causality
    • Writing of case narratives, Dear Doctor Letters
    • CIOMS report generation
    • MedDRA Coding
    • Expedited reporting to federal authorities, Ethics Committees and investigators
    • Case processing, including data entry, narrative generation, and quality-control
    • Validation and analysis of AE data, AE listing generation
    • Clinical/Safety data reconciliation of AE/SAEs
    • Qualified medical review
      • MedDRA coding review
      • Trend analyses┬á(Safety Monitoring)
      • Risk management

CONET's drug safety team provides thorough examination and quality control of all safety reports, yielding complete and accurate information during your clinical trial.

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