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.
Phases of clinical trials:
initial assessment of the drug's safety and pharmacological properties, a group of several dozen healthy volunteers, positive results enable the transition to phase II.
determining the dose, preliminary analysis of the safety and efficacy of the drug, a group of several hundred patients with a specific type of disease, positive results enable the transition to phase III.
confirmation of the effectiveness and safety of the drug, a group of several thousand patients. positive results allow the drug to be registered and introduced to the market.
studies of registered and marketed drugs, confirmation of long-term efficacy and safety of the drug, new indications for an already registered drug are also tested.
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),
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,
, 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.
Which phases of clinical trials for medicinal products do you handle?
At BioStat, we provide comprehensive clinical trial services. For medicinal products, we can coordinate any phase of a clinical trial (I-IV).
To what extent do you handle clinical trials of medicinal products?
As the BioStat Research and Development Center, we can provide comprehensive clinical trial services for drugs. Starting from the legal and formal aspects, through contracting centers and researchers, to managing collected data and preparing statistical analyses.
Do you conduct clinical drug trials in electronic or paper form?
Almost all clinical trials (about 97%) are carried out using our proprietary eCRF.biz system, compliant with FDA guidelines. The application is always adapted to the specifics of the trial.