Comprehensive Service for Non-Interventional Studies

Biostat specializes in the planning, organization, execution, and data processing of non-interventional research. With 18 years of experience collaborating with medical, pharmaceutical, and biotechnology companies, we bring a wealth of knowledge and expertise to the table.

Our Offerings

We provide a wide range of non-interventional studies, including:

• Observational studies
• Epidemiological studies
• Patient educational programs
• Post Authorization Safety Study (PASS)
• Post Authorization Efficacy Study (PAES)
• Medical registries
• Post-marketing surveillance (PMS)
• RX to OTC switch studies
• "Case study" surveys

Clientele and Therapeutic Areas

Our clients range from medical centers to pharmaceutical and biotechnological companies. We conduct studies across various therapeutic areas, such as neurology, oncology, psychiatry, gastroenterology, transplantology, diabetology, dermatology, surgery, and rheumatology. Our experts utilize state-of-the-art biostatistical tools and methodologies in their daily practice.

Expert Team and Scientific Contributions

Our team comprises specialists in project management, biotechnology, biology, biostatistics, bioinformatics, and data management. Their work is frequently published in scientific journals featured in the Master Journal List. The results of our studies are presented at medical conferences both domestically and internationally, ensuring that our findings contribute significantly to the scientific community.

Guarantee of Credibility and Reliability

Our team's high qualifications, scientific backgrounds, and extensive experience in collaboration with clinical experts and pharmaceutical companies ensure that our clients receive credible and reliable services.

Services Provided for Non-Interventional Studies (NIS)

For non-interventional studies, we offer a comprehensive suite of services, including:

• Study design (protocol preparation and observation questionnaire)
• Preparation and consultation of study documentation
• Contracting sites and investigators
• Collaboration with Ethics Committees and Regulatory Authorities
• eCRF preparation using a dedicated Key Visual
• Training for sponsors and investigators
• Comprehensive statistical services (SAP, interim analysis, statistical report, and final data presentation)
• Assistance in the preparation of publications
• Study management
• Site management
• Data management
• Progress status reporting
• Supervision of adverse event reporting
• Investigator's financial settlements

Innovative Electronic Data Capture System

We conduct all studies using our in-house, innovative Electronic Data Capture (EDC) system, eCRF.biz, which integrates the best features for every type of study. This platform is designed to meet the specific needs of pharmaceutical companies and academia, providing secure, encrypted data access in compliance with Title 21 CFR Part 11 guidelines.

Quality and Efficiency with eCRF.biz

The eCRF.biz software ensures the highest quality of study execution, with automatic data quality and completeness control during registration. It also includes extensive reporting mechanisms for ongoing study progress monitoring. Enhanced with control mechanisms, an audit trail, data query capabilities, and data backup, the system prepares data for complex statistical analyses conducted by our team.

Streamlined Contract Management with e-Signing

BioStat (CRO in Poland) has implemented a new electronic module for e-signing agreements. This feature optimizes the contracting process, eliminating the need for scans, document printing, and courier services. Using the e-contracting function via the eCRF system speeds up the finalization of contracts, annexes, and payments with investigators, reducing the time spent waiting for paper documentation.

Three Simple Steps to Signing Agreements

Signing agreements has never been easier or more transparent with our three-step process:

1. Registration: The user fills in a registration form.
2. Verification: After registration, the contract and regulations are sent to the user’s email address for verification.
3. Confirmation: The user reviews the contract and regulations and confirms them by clicking the link in the email.

Once signed, the document is automatically saved and sent to the user as a PDF attachment in a second email.

By simplifying the signing process, we ensure efficiency and transparency, making it easier for all parties involved.