Clinical trials
of medical devices..

eCRF | Statistics | Data management

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Clinical trials on medical devices are conducted in Poland significantly less than clinical trials on drugs. The aim of clinical trials of medical devices is to obtain clinical data on the basis of which the clinical evaluation of the device is made.
A medical device (in accordance with Act of 20 May 2010 on Medical Devices) is: a tool, instrument, device, software, material or other article, used alone or in combination, in including software intended by its manufacturer for use specifically for diagnostic or therapeutic purposes and necessary for its proper application, intended by the manufacturer for human application for the purpose of:
  • Diagnosis, prevention, monitoring, treatment or alleviation of disease.
  • Diagnosis, monitoring, treatment, alleviation of, or compensation for, an injury or handicap.
  • investigating, replacing or modifying the anatomical structure or physiological process of conception regulation which does not achieve the principal intended effect in the body or on the human body by pharmacological, immunological or metabolic means, but whose action can be aided by such means.
As part of clinical trials of medical devices, we provide:
  • Full statistical support for the research (preparation and consultation of the statistical section in the protocol, selection of the sample size, justification, Statistical Analysis Plan, interim analysis, final statistical analyzes, statistical reports, tables, listings, help in preparing the publication),
  • Preparation of the eCRF system based on the proprietary eCRF.biz ™ software with the preparation of complete validation documentation (including validation report, validation certificate, etc.)
  • Data management, which consists of: managing accounts of the eCRF system users, preparing a Data Management Plan, edit checks, developing a database structure and central verification of the quality of data entered into the eCRF system.
  • Integration with laboratories.
Wyroby medyczne
Other eCRF system functions.
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