Quality Assurance

Quality control is one of the main key to guarantee the data are high qualitative and reliable.
All team members are trained on Good Clinical Practice (GCP), applicable SOPs and protocol-specific requirements prior and during conducting clinical trials activities. Training on GCP and SOPs are performed on a regular basis for the entire staff.
Thus, we ensure that all procedures are under strict control.

  • Quality Assurance
    • Internal quality assurance
    • External site, study audits
    • Guidance for the client towards optimization of quality assurance and controlling systems
    • Preparation for audits and inspections
    • Project audits, e.g. investigator files audits, trial master file audits, clinical study report audits and regulatory submission audits
    • Implementation of corrective and preventive action plans (CAPA) and help to improve performance

Please feel free to contact us anytime for more information!

CLAUSE’s team is at your service:

  • Start-up Services
  • Regulatory affairs
  • Project Management
  • Clinical Monitoring
  • Quality Assurance / Management
  • Data management services

News and events

Clause will participate in Arabian Health
24.01.2017
Clause will participate in Arabian Health

News
21.09.2016
CLAUSE Ltd, the leading contract research organization in Europe is pleased to announce the opening of a new branch office in Praha, Czech Republic.

Сontacts

We will be glad to cooperate

Feel free to contact us for any questions using any convinient way for you!

Tel +38 095 596 0666; +38 057 751 66 99

e-mail: office@clause-audit.com

Address: 20V, Kul'tury str., off.19

Kharkiv ,61058,Ukraine

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