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.
What is included in the scope of your services for clinical trials of medical devices?
In clinical trials of medical devices, we are responsible for preparing project documentation, monitoring, statistical services, preparation of eCRF and data management, contracting centers and researchers, and project management.
What is the preparation time for the eCRF.biz™ system for a clinical trial?
The waiting time to build the eCRF.biz™ system configured for a specific clinical trial is always tailored to the client's expectations, but the average time is about 1.5-2 months.
How does digital transformation impact the efficiency of research teams?
Improved oversight of the study progress,
Rapid response to potential issues,
Easier implementation of changes resulting from protocol modifications and acquiring missing data through queries to researchers,
Automation and standardization of tasks related to Data Management,
Enhancing eCRF explanations and comments in response to questions from researchers,
Faster preparation of the database for analysis (interim and final),
Integration of tools related to eCRF with tools facilitating documentation collection and reporting (CTMS, eTMF).