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Interventional Studies - Phase I-IV

Interventional Studies

Phase I-IV

With the completion of a significant number of projects, covering a broad range of therapeutic areas, we offer a portfolio of proven experience in Interventional Studies. Our well trained professionals are readily available to meet project needs and provide solutions, advice and local expertise. 

 

Services that ZEINCRO provides in the field of Interventional Studies are:

Clinical Trials Management

  • Study planning & set up
    • Feasibility
    • Site screening & selection
    • Organization & conduct of Investigator’s meetings
    • Planning, budgeting & resourcing
    • Trial files construction
    • Submissions to IRBs & regulatory authorities
    • Trial initiation
  • Study conduct
    • Study monitoring
    • Project management
    • Safety reporting
    • Essential documents maintenance
    • Continuous communication with investigators, regulatory authorities & IRBs
  • Study close out
    • Site closing
    • Trial files finalization & archiving
    • IRB & regulatory authorities reporting

 

Medical Affairs

  • Concept development & evaluation
  • Protocol writing, editing and reviewing
  • Patient documents development
  • Case Report Form design
  • Study Manual development
  • Safety review
  • Medical support & advise during study conduct
  • Translation of medical documents
  • Clinical study report preparation
  • Medical writing

 

Training

  • Training courses on ICH GCP guidelines and local legislation
  • CRA introductory and advanced training
  • Tailor made training courses on clinical research
  • Investigators’ training
  • Therapeutic area specific training

 

Interest Form

  • Interested for more information?

     
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  • Interventional Trials - Phase I - IV
    Non Interventional Trials - Post Authorization Safety and Efficacy Studies
    Regulatory Affairs
    Pharmacovigilance
    Other
     
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  • We respect your privacy. We will not share, lease or sell your contact information.

     

ABOUT US

ZEINCRO is a leading contract research organization covering more than 21 countries in Europe, with a special focus in the region of Central and South Eastern Europe (Albania, Austria, Bulgaria, Cyprus, Czech Republic, Germany, Estonia, FYROM, Greece, Hungary, Latvia, Lithuania, Malta, Moldova, the Netherlands, Poland, Romania, Slovakia, Switzerland, Turkey and Ukraine).

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CONTACT US

  • Email:  info@zeincro.com

ZEINCRO : member of

European CRO Federation (EUCROF)

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