BioStat (CRO): leading the way in clinical trials of medicinal products

BioStat is at the forefront of conducting clinical trials for medicinal products, playing a pivotal role in introducing new drugs to the market and evaluating the therapeutic value of existing ones. Our work supports pharmaceutical and biotechnology companies in their quest to discover more effective treatments and bring them to patients who need them.

The Journey of a Drug: From Concept to Market

A medicinal product, commonly known as a drug, is designed to prevent or treat specific diseases. Before a drug becomes widely available, it must undergo rigorous preclinical and clinical trials. In Poland, the Office for Registration of Medicinal Products, Medical Devices, and Biocidal Products issues the necessary marketing authorizations.

There are two primary types of medicinal products:

• Innovative Drugs (Reference Drugs): New drugs introduced to the market.
• Generic Drugs: Replacements for innovative drugs, offering the same therapeutic benefits.

Phases of Clinical Trials

Phase I:
This initial phase involves a small group of healthy volunteers to assess the drug's safety and pharmacological properties. Positive results from Phase I allow progression to Phase II.

Phase II:
This phase involves several hundred patients with a specific disease to determine the optimal dose and conduct a preliminary analysis of the drug's safety and efficacy. Successful results enable the transition to Phase III.

Phase III:
Involving several thousand patients, Phase III aims to confirm the drug's effectiveness and safety. Positive outcomes in this phase allow the drug to be registered and marketed.

Phase IV:
Post-marketing studies focus on long-term efficacy and safety, as well as exploring new indications for the already registered drug.

Extensive Experience in Therapeutic Areas

BioStat - CRO in Poland conducts both single- and multi-center research in Poland and internationally. Our expertise spans numerous therapeutic areas, including:

• Oncology
• Ophthalmology
• Dermatology
• Psychiatry
• Allergology
• Invasive Cardiology
• Neurology

Comprehensive Clinical Trial Services

In our clinical trials, we primarily operate under the Sponsor - CRO - BioStat model, ensuring a seamless and effective research process. Our responsibilities include:

• Statistical Services: Comprehensive statistical support, including preparation and consultation of the statistical section in protocols, sample size calculation, survey justification, preparation of the Statistical Analysis Plan, and production of statistical reports, tables, and listings.
• eCRF Design: Utilizing our proprietary eCRF.biz™ software, we design electronic Case Report Forms (eCRFs) based on study protocols, accompanied by full validation documentation.
• Randomization Systems: Developing robust randomization systems, often integrated with drug distribution and dispensing management functions (IVRX, IxRS), along with preparation of randomization lists.
• Data Management: Managing eCRF system user accounts, preparing Data Management Plans, conducting edit checks, developing database structures, and ensuring central verification of data quality entered into the eCRF system.
• Laboratory Integration: Facilitating integration with both central and local laboratories to ensure efficient and accurate data handling.

Commitment to Excellence

BioStat®'s dedication to high-quality research and our extensive experience in various therapeutic fields position us as a leader in clinical trials of medicinal products. By partnering with BioStat®, pharmaceutical and biotechnology companies can trust in our expertise to deliver precise, timely, and reliable results, ultimately contributing to the development of new and improved treatments for patients worldwide.