BioStat (CRO in Poland): pioneering clinical trials for medical devices

Understanding Medical Devices

According to the Act of 20 May 2010 on Medical Devices, a medical device encompasses tools, instruments, devices, software, materials, or other articles used alone or in combination. These devices, intended by the manufacturer for diagnostic or therapeutic purposes, serve various functions, including:

• Diagnosis, prevention, monitoring, treatment, or alleviation of diseases.
• Diagnosis, monitoring, treatment, alleviation of, or compensation for, injuries or disabilities.
• Investigating, replacing, or modifying anatomical structures or physiological processes.
• Regulating conception without achieving the primary intended effect through pharmacological, immunological, or metabolic means, though these actions can be supported by such means.

Badania kliniczne - z perspektywy małego pacjenta i rodzica

Comprehensive Clinical Trial Services for Medical Devices

BioStat (CRO in Poland) offers extensive services to support clinical trials of medical devices, ensuring thorough and accurate evaluation through various stages of research:

• Statistical Support: Providing comprehensive statistical services, including the preparation and consultation of the statistical section in protocols, sample size determination, justification, Statistical Analysis Plans, interim and final statistical analyses, reports, tables, and assistance in preparing publications.
• eCRF System Preparation: Utilizing our proprietary eCRF.biz™ software, we design and validate electronic Case Report Forms (eCRFs) with complete validation documentation, including validation reports and certificates.
• Data Management: Managing eCRF system user accounts, preparing Data Management Plans, conducting edit checks, developing database structures, and verifying the quality of data entered into the eCRF system centrally.
• Laboratory Integration: Ensuring seamless integration with laboratories to facilitate efficient data collection and analysis.

Advanced eCRF System Functions

Our eCRF system is equipped with advanced features to enhance the clinical trial process:

• Automatic Reports: Generating real-time reports to track trial progress.
• Comments: Allowing users to annotate data entries for clarity and context.
• Online Contracts: Facilitating digital contract management.
• Protocol Deviation Log: Tracking any deviations from the study protocol.
• Audit Trail: Maintaining a comprehensive record of all data changes and user activities.
• Data Query: Enabling efficient resolution of data discrepancies.
• MedDRA Dictionary: Utilizing standardized medical terminology for data consistency.
• Randomization: Supporting the random allocation of study participants.
• Notifications: Providing timely alerts to keep the trial team informed.

Ensuring Excellence in Medical Device Trials

At BioStat®, we are committed to excellence in every clinical trial we conduct. Our comprehensive services and advanced technological solutions ensure that each trial is conducted with the utmost precision, reliability, and compliance with regulatory standards. Partner with BioStat® to ensure your medical devices are rigorously tested and validated, providing confidence in their safety and efficacy for the patients who rely on them.