Clinical trial management

We manage clinical trials based on the designated teams led by experienced Project Managers. The Project Managers are responsible for the proper communication between all involved parties, smooth running of the project, and all agreements made with the sponsor on timelines, quality and costs of the trial.

These teams include well-educated and experienced Clinical Research Associates.

  • KCRI is able to assist with the management of regulatory affairs. We help with a successful submission of a trial to the regulatory authorities and local Review Boards in Poland, in compliance with all respective local and European laws and regulations.

  • KCRI also can provide advice on selection of the trial sites (in terms of the volume, expertise, equipment), as well as initiate and manage contacts with these sites.

  • The organization of investigators meetings, design and development of additional trial materials and manuals, training of the research personnel and formulation of progress reports are also our responsibilities.

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For the companies located outside the European Community we may act as your Regulatory Authorized Representative. We provide professional regulatory support of your medicinal products and medical devices for Europe, according to the guidelines of MDD 93/42/EEC and EN 46002