Clinical Auditing

CLAUSE ltd offers the full range of auditing and consulting services in the field of clinical research.

Our team is highly competent and experienced in ICH GCP clinical trials conducting and auditing. Our knowledge of international guidance and ethical principles, knowledge of regulatory legislation, understanding the processes “inside and out” allows us to succeed on each stage of our work.

Professionally conducted audit will bring significant value to a client. It is the guarantee of your assurance in reliability of the clinical data and conformity of these data, clinical trial to the international and local regulatory requirements.
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  • Clinical Auditing
    • Clinical trial audit (Phase I, II, III ,IV)
    • Pre-clinical trial audit
    • Audit of CRO Quality Management System
    • Assessment audit of CRO
    • Trainings for CRO employees and investigators
    • Preparation for Regulatory Inspections
    • Laboratory audit according to GCLP requirements
    • Testing of CRO employees on the subject of knowledge of international and local requirements for clinical trials
    • Consulting and QA support on issues of clinical and pre-clinical studies

For more detailed information, please see clause-audit.com website and feel free to contact us anytime!

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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