Full-Service CRO. Clinical Research

CRO

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) with 20 years of experience, which provides a comprehensive service in commercial and non-commercial clinical trials. We specialize in phase I-IV trials and observational studies. Biostat provides a full range of CRO services, including clinical data management and clinical project management. We operates in Poland and CEE (Central Eastern Europe).

Whether you are looking for a CRO Partner in Poland 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.

 

In conducting clinical trials in Poland and CEE, we collaborate with partners who have global clinical trial projects, including Astra Zeneca, Celon Pharma, Chiesi, Egis, Ipsen, Pfizer and Takeda  as well as Research Institutes and Medical Universities.

Who we are?

Leader on the Polish market in providing professional and innovative solutions in the area of clinical trials and observational studies, statistics, medical software, telemedicine and R&D.

Commercial research unit with status of a Research and Development Centre (R&DC) granted by the Minister of Entrepreneurship and Technology.
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+20
Years of experience
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+70
Experts
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+2000
Studies
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+500
Publication
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Audits

BioStat Full-Service CRO:

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
Monitoring
Statistics
Regulators
Feasibility
Pharmacovigilance
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
  • Full-Service CRO
     

Therapeutic areas

Projects implemented in various fields:
Transplantology
Pulmonology
Oncology
Immunology
Psychiatry
Proctology
Cardiology
Andrology
Neurology
Virology
Allergology
Hematology
Gastroenterology
Rheumatology
Neonatology
Dermatology
Diabetology
Ophthalmology
person

Recommendations

Our solutions

Active Studies

Frequently asked questions.

In what fields of clinical or observational research can BioStat 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 eCRF.biz™ 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, eCRF.biz™. 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.
 
Are you a full service CRO?

Yes, we provide full service CRO in Central Eastern Europe. We are located in Poland.

What therapeutic areas do you have experience in?

We have the resources and expertise to conduct a study in any field. We have the most experience in such therapeutic areas as oncology, gastroenterology, transplantology, cardiology, neurology, allergology, psychiatry, neonatology, diabetology, pulmonology, immunology, andrology, proctology, dermatology, ophthalmology, rheumatology, virology or hematology. To date, we have provided CRO services in Poland and other European countries.

Do you have experience working with global pharmaceutical companies?

Yes, among the partners we provide CRO services for are Astra Zeneca, Celon Pharma, Chiesi, Egis, Ipsen, Pfizer and Takeda.

What is included in your services for a clinical/observational study?

We provide comprehensive services for clinical and observational studies. We are responsible for statistical handling of the study, preparation of eCRF and data management, preparation of project documentation, monitoring, obtaining necessary administrative approvals, contracting of sites and investigators, project management, training, etc.

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