Clinical trials of medicinal products..
eCRF | Statistics | Data Management
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The dominant part of clinical trials conducted by BioStat® is research on the introduction of new drugs to the market. We help pharmaceutical and biotechnology clients in the process of searching for new, more effective drugs, but also in the evaluation of existing drugs, the therapeutic value of which is not fully known.
A medicinal product commonly known as a drug, is a substance or mixture of substances with the properties of preventing or treating specific disease entities.
Before a drug becomes widely used, it must go through a process of preclinical and clinical trials. In Poland, a marketing authorization is issued by the Office for Registration of Medicinal Products, Medical Devices and Biocidal Products.
There are two types of medicinal products: an innovative drug (also known as the reference drug) and a generic drug, which is a replacement for an innovative product.
We conduct single- and multi-center research in Poland and abroad. Therapeutic areas in which we have so far conducted clinical trials for medicinal products include:
During the research, we mainly work in the model Sponsor - CRO - BioStat®, being responsible for:
- comprehensive statistical service of the survey (preparation and consultation of the statistical section in the protocol, calculation of the sample size, justification of the survey, preparation of the Statistical Analysis Plan, partial analyzes, final analyzes, statistical reports, tables, listings),
- designing eCRF on the basis of a protocol using the proprietary eCRF.bizTM software with the preparation of full validation documentation,
- building a randomization system , often enriched with the functions of drug distribution / dispensing management (IVRX, IxRS) and preparation of a randomization list,
- 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 central and / or local laboratories.