BioStat is a commercial research unit which has the status of a Research and Development Centre. We are a Polish CRO company (Clinical Research Organization), which provides a comprehensive service in commercial and non-commercial clinical trials. We specialize in phase I-IV trials and observational studies.

Whether you are looking for a Partner to support you throughout the clinical development process or simply looking for additional specialized support, Biostat can help by providing a team of experts who are proficient in planning and conducting clinical trials and then navigating the regulatory approval process.

As part of the trial, we provide the following services:

Project management
Trial documentation
Medical Writing
Site Management
Systems for clinical trials
Data management
  • Coordination and management of projects at all stages: from set up to closure
  • Trial reports
  • Supervising the operation of monitors
  • Management of vendors
  • Contracting centres and researchers
  • Working with Key Opinion Leaders
  • Trainings
  • Risk management
  • Agreements
  • Patient Information
  • Informed consent forms
  • Trial plans (communication plan, study monitoring plan, study management plan, data management plan, quality management plan, protocol deviation management plan, etc.)
  • Procedures
  • Instructions
  • Forms
  • Logs
  • Protocol summary
  • Trial Protocol
  • Clinical Study Report, CSR
  • Publications
  • Communication with centres
  • Trainings of the research team
  • Electronic Data Capture System, EDC
  • Interactive Web Response System, IWRS
  • Electronic Patient Reported Outcome, ePRO
  • eTMF (electronic Trial Master File)
  • Data Management Plan, DMP
  • Data Validation Plan, DVP
  • Medical coding
  • Database cleansing
  • Day-to-day data management, quality control
  • User account management
  • Query management
  • Reconciliations
  • Onsite and remote monitoring (selection, initiation, monitoring, closing visits)
  • Remote monitoring
  • Targeted Monitoring
  • Sample size calculation
  • Statistical input for the protocol
  • Statistical Analysis Plan (SAP)
  • Mid-term analyses
  • Final analyses
  • Statistical reports
  • Preparation of applications to the Office for Registration of Medicinal Products and Biocidal Materials and to Bioethics Committees
  • Clinical Trial Application, CTA
  • Correspondence with regulatory authorities
  • Notifications
  • Identification of potential centres
  • Feasibility questionnaire and a report summarising the results of the process
  • Analysis of recruitment potential and feasibility of the trials in the centres
  • Pharmacovigilance
  • Safety Management Plan, SMP
  • SOPs/Instructions
  • AE/SAE/SUSAR support
  • DSUR reports
  • EudraVigilance database support
  • Co-monitoring visits
Quality Assurance

Our key features

  • Original eCRF.bizTM system
    compliant with FDA guidelines (Title 21 CRF Part 11).
  • Digitalization of processes and seamless integration of databases:
    eCRF, eTMF and CTMS
  • Fast decision-making path
  • Professional statistics,
    compliant with FDA and Master Journal List standards (Philadelphia list)
  • Stable, committed and experienced team


Our solutions


Frequently asked questions.

In what fields of clinical or observational research can a CRO (Contract Research Organization) assist?
We possess the resources and knowledge to conduct studies in any field. Our portfolio includes completed projects in various areas such as neurology, allergology, oncology, gastroenterology, transplantology, andrology, proctology, dermatology, cardiology, psychiatry, neonatology, diabetology, ophthalmology, rheumatology, virology, pulmonology, immunology, and hematology.
Does the Biostat offer include site contracting?
Yes, Biostat® provides site and researcher contracting services for both clinical and observational research. We negotiate bilateral, trilateral, and quadrilateral agreements. Trilateral and quadrilateral agreements are executed in the traditional paper format. For bilateral agreements, we utilize the™ system's online contracting feature, eliminating the need for printing, scanning, and couriering documents. We also handle financial and accounting reconciliation processes.
Does Biostat prepare medical registries?
Yes. In pursuit of improving the quality and safety of healthcare service delivery, we offer assistance in preparing medical registries using our research platform,™. We create medical registries as tools for collecting data about patients with specific diagnoses, medical conditions, patients undergoing particular therapies, specific procedures – for instance, registries of procedures or surgeries, patients treated with specific medicinal products or medical devices – such as registries of implanted hip joint prostheses.
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