BioStat: Your Premier Partner CRO in Clinical Trials
For over 15 years, BioStat® has been a leading provider of high-quality services to the pharmaceutical, biotechnology, and medical device industries. Specializing in commercial and non-commercial clinical trials from phases I to IV, BioStat® ensures that clients achieve their clinical research goals with precision and efficiency.
Leading the Way in Clinical Trials
BioStat (CRO in Poland) has built a reputation for excellence in managing, planning, data processing, data management, and statistical services, delivering each clinical trial on time and in compliance with local and international regulations. Our adherence to Good Clinical Practice (GCP), our Standard Operating Procedures (SOPs), and those of our sponsors guarantees that all metrics concerning time, cost, and quality are met. This dedication to excellence allows us to offer a comprehensive portfolio of services tailored to meet the individual needs of each client.
Our extensive range of services includes:
- Clinical Trials of Investigational Medicinal Products
- Clinical Trials of Medical Devices
- Bioequivalence Studies
- Investigator Initiated Studies
- Clinical Trials of Cosmetics and Dermocosmetics
Expertise Across Therapeutic Fields
BioStat®'s team is highly experienced in conducting English-language studies both in Poland and abroad. Our expertise spans numerous therapeutic fields, including oncology, invasive cardiology, allergology, dermatology, gastroenterology, psychiatry, ophthalmology, neurology, and more. This breadth of experience positions us to tackle new challenges continually, leveraging the full potential of our proprietary eCRF.biz™ system for electronic data collection and efficient process management.
Comprehensive Clinical Trial Services
Our robust scope of services ensures that all aspects of clinical trials are meticulously handled:
- Study Design: Collaborating with Key Opinion Leaders on hypothesis formation, sample size calculation, and publications review.
- Statistical Services: Offering a full suite of statistical services including Statistical Analysis Plans (SAP), interim analyses, final statistical reports, and data presentation.
- Study Documentation: Preparation and consultation, ensuring all documentation meets regulatory standards.
- Site and Investigator Contracting: Managing negotiations and contracting to secure the best sites and investigators.
- Regulatory and Ethics Compliance: Working closely with ethics committees and national regulatory authorities.
- Data Management: Developing database structures, performing quality control, and ensuring data integrity through comprehensive management practices.
Advanced Technological Solutions
BioStat® integrates advanced technological solutions to streamline clinical trials:
- eCRF Preparation: Creating and programming databases tailored to study needs.
- Patient Observation: Developing electronic diaries (PRO) for patient data collection.
- IWRS and Drug Management: Implementing interactive web response systems and drug management solutions.
- Laboratory Integration: Ensuring seamless integration with local and central laboratories for efficient data handling.
- Adverse Event Reporting: Supervising adverse event reporting to ensure patient safety and regulatory compliance.
- Training and Support: Providing extensive training and support through our helpdesk, assisting with study result presentations, and aiding in the preparation of scientific publications.
Our Team of Experts
BioStat® boasts a team of highly qualified experts including project managers, biotechnologists, biologists, statisticians, biostatisticians, and data managers. Their analyses and contributions meet the highest standards, as reflected in the Master Journal List, ensuring that our clients receive unparalleled service and support in achieving their research objectives.
In summary, BioStat® is committed to pioneering excellence in clinical research, delivering tailored solutions that meet the highest standards of quality, time, and cost efficiency. Partner with BioStat® to ensure your clinical trials are conducted with the utmost precision and professionalism.