Regulatory affairs

During the whole study our regulatory managers will provide you with the regulatory support for your clinical trial.

  • Regulatory affairs
    • Processing subject insurance and also local insurance policies, if required
    • CTA (Clinical Trial Application) preparation, submission and management
    • Procurement and management of import and export licenses for IMP and study material, customs administration, if required
    • Processing of protocol amendments and revisions to patient informed consent forms and information sheet

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
Clause will participate in Arabian Health

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


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


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

Kharkiv ,61058,Ukraine

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