CRO providing a full service
in clinical trials and non-
interventional studies.

CLINICAL TRIAL | ONCOLOGY

A Phase I, Open-label, Multicentre, Dose Escalation Study to Assess Safety, Tolerability and Pharmacokinetics of Oral CP ...

CLINICAL TRIAL | ONCOLOGY

A Randomized, Open-label Phase 3 Study in Patients With Newly Diagnosed Multiple Myeloma

CLINICAL TRIAL | CARDIOLOGY

The intravenous treatment’s influence on the mortality and morbidity from cardiovascular causes, and on the quality of l ...

CLINICAL TRIAL | ONCOLOGY

Pre-emptive therapy of minimal residual disease reappearanceor biochemical relapse in multiple myeloma

DRUG REGISTRY | ONCOLOGY

Drug registry with the analysis of treatment results in Polish patients with cutaneous T-cell lymphoma (CTCL).

OBSERVATIONAL STUDY

An international, observational study based on secondary data describing the management and treatment in routine practic ...

OBSERVATIONAL STUDY | GASTROENTEROLOGY

Evaluation of biological treatment’s distant effects in patients with ulcerative colitis in Poland. Non-interventional o ...

CLINICAL TRIAL | DEMO

A multicentre, randomized, placebo-controlled phase III study to compare efficacy and safety of Oral Drug ZX37200 in sub ...

OBSERVATIONAL STUDY | TRANSPLANTOLOGY

The influence of the concentration/dose ratio and other clinical variables on kidney function in kidney transplant recip ...

OBSERVATIONAL STUDY | GASTROENTEROLOGY

Clinical efficiency of vendolizumab used in the Crohn’s disease treatment as part of the Drug Program. Prospective, obse ...

Free medical consultations | PULMONOLOGY

Complimentary medical consultations

SINGLE-CENTRE CLINICAL TRIAL

Phase 1 trial on the drug safety and pharmacokinetics in patients with relapsed or refractory B-cell acute lymphoblastic ...

OBSERVATIONAL STUDY | ONCOLOGY

Efficacy and safety of the drug in the first-line treatment of ALK-positive non-small cell lung cancer (NSCLC).

CLINICAL TRIAL | PAEDIATRIC NEPHROLOGY

Early treatment in patients with idiopathic nephrotic syndrome.

MULTICENTER OBSERVATIONAL STUDY

Early treatment of heart failure: a non-interventional observational study in patients with heart failure and initiated ...

CLINICAL STUDY | NEUROLOGY

Reperfusion thrombolytic therapy for ischaemic stroke in patients on the non-vitamin K antagonist oral anticoagulants

OBSERVATIONAL STUDY | IMMUNOLOGY

Efficiency and safety of consolidation treatment in patients with Hodgkin’s lymphoma (HL) undergoing autologous stem cel ...

CLINICAL TRIAL | ONCOLOGY

The influence of irreversible calcium electroporation, electrochemotherapy and electroporation on the quality of life an ...

OBSERVATIONAL STUDY | ALLERGOLOGY

Evaluation of the therapeutic effect of a drug used in Polish patients with hereditary angioedema as part of the Drug Pr ...

CLINICAL TRIAL | PAEDIATRIC DIABETOLOGY

Randomized, double-blind, placebo-controlled, parallel group multicenter study on the evaluation the efficacy and safety ...

CLINICAL TRIAL | CARDIOLOGY

A medicine for PREVENTion of Myocardial Injury after Noncardiac Surgery

CLINICAL TRIAL | CARDIOLOGY

Safety and efficacy evaluation of two antiplatelet deescalating strategies in the acute coronary syndrome.

CLINICAL TRIAL | ONCOLOGY

Preoperative intraperitoneal chemotherapy in hyperthermia complementing combined treatment in the advanced stomach cance ...

CLINICAL STUDY | PSYCHIATRY

Phase II, Double blind, Randomized, Placebo controlled, Parallel group, Trial to Explore Efficacy, safety and pharmacok ...

RANDOMIZED CLINICAL TRIAL

Comparison of the efficacy of two vitamin D3 doses in critically ill patients undergoing continuous renal replacement th ...

OBSERVATIONAL STUDY | GASTROENTEROLOGY

Prospective, non-interventional observational study in patients with inflamed bowel disease receiving drug subcutaneousl ...

OBSERVATIONAL STUDY

Clinical characteristics associated with a favorable response to surfactant in premature infants ≥34 weeks of gestationa ...

CLINICAL TRIAL | ONCOLOGY

Immunotherapy in the advanced, progressive cancer of the adrenal cortex treatment.

PATIENT SUPPORT PROGRAM

Actively monitoring stroke patients for spasticity.

CLINICAL TRIAL | NEUROLOGY

Phase II, Double blind, Randomized, Placebo controlled, Parallel group, Trial to Explore the Potential Anti-dyskinetic P ...

CLINICAL TRIAL | DIABETOLOGY

A Phase 2, Double-Blind, Randomized, Placebo-Controlled, Parallel-Group Study to Evaluate Efficacy, Safety and Pharmaco ...

OBSERVATIONAL STUDY

Evaluation of safety and efficacy of combined therapy in comparison to monotherapy in patients with hypertension

OBSERVATIONAL STUDY | PEDIATRICS

Annual registry of Gram-negative infections in the Pediatric Intensive Care Units (PICUs) in Poland.

CLINICAL TRIAL | CARDIOLOGY

Neuroprotection in percutaneous occlusion of the left atrium appendage in patients with atrial fibrillation.

CLINICAL TRIAL

A 12-week, phase II, multicentre, randomised, double blind, efficacy and safety study comparing CPL409116 to placebo, in ...

RESEARCH EXPERIMENT

A single-center, randomized, open-label study to evaluate the safety and efficacy of renal artery denervation therapy wi ...

SINGLE-CENTRE CLINICAL TRIAL

Chronic drug use as a prognostic factor for reduced susceptibility to SARS-CoV-2 virus infection in drug-exacerbated res ...

CLINICAL TRIAL

Implementation of lymphocytes in the treatment of adult patients with relapsed and refractory acute lymphoblastic leukem ...

CLINICAL STUDIES | CARDIOLOGY

Evaluation of the safety and effectiveness of the cardiac cryoablation system in the treatment of atrial fibrillation.

OBSERVATIONAL STUDY

Real-world treatment outcomes in Polish patients with systemic lupus erythematosus (SLE). Multicenter, non-interventiona ...

NEUROLOGY

Neurostimulation for the treatment of post stroke aphasia

OBSERVATIONAL STUDY | ONCOLOGY

Multicenter, open-label, observational study assessing the effectiveness and safety of therapy in patients with high-ris ...

OBSERVATIONAL STUDY

Real-life treatment outcomes of monoclonal antibody IgG2/4K in Polish patients with paroxysmal nocturnal hemoglobinuria ...

OBSERVATIONAL STUDY | DEMO

Effect of statin X treatment on cholesterol levels in patients after myocardial infarction.

Active trials

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Biostat provides the comprehensive clinical development services, from First-in-Human
through Phase IV and post-marketing studies. Main researches offered by Biostat include:

Clinical trials - medical product

Full service product development from early phases to final
phase III CSR for marketing authorization

Project Management
Central Authority/Ethics Committee approvals
Feasibility process
Monitoring
Statistics
Medical writing
Study documentation
Trainings
Study tools (eCRF, ePRO, eTMF and all other required IT support)
Data management
Safety management

Scientifical and marketing studies

Clinical investigation - medical devices

Full service device development from early stages to complete,
MDR compliant clinical evidence required for CE Mark application

Full CE Mark aquisition process support
MDR compliant clinical investigation design/methodology
Project Management
Central Authority/Ethics Committee approvals
Feasibility process
Monitoring
Statistics
Medical writing
Study documentation
Trainings
eCRF/Data management
Safety management

Non-interventional studies – observational, prospective, retrospective

Project Management
Site identification (Poland/EU countries) and feasibility process
Study documentation
Ethics Commitee approvals
Sites/Investigators contracting Trainings
Study monitoring
eCRF/ePRO/Data management
Statistical analyses, CSR, publications assistance

Statistics

Statistical Analysis
Statistics for clinical research
Data Modeling and econometrics
Biostatistics
Training and consulting

eCRF

Medical device clinical trials
Cosmetic and dermocosmetic clinical trials
Bioequivalence studies
Investigator Initiated Studies

Other studies

Real-World Evidence studies
Investigator Initiated Studies
Post Marketing Surveillance
Post Authorization Safety Studies
Post Authorization Efficacy Studies
Patient’s medical records
Medical registry
Studies of an Rx-to-OTC switch

Market research

„The cooperation has concerned survey organization, consulting and statistical analysis of quantitative research. We are indeed thankful to Rafal Piszczek for his reliability and professionalism in doing his duties as well as for his creative contribution on the projects being conducted by Amgen.”

The company completed the survey and statistical analysis of the conducted research project on the risk assessment during the operation of portable computer equipment in a timely manner. The performance received our positive opinion.

„The BioStat company provides professional support and services. The BioStat team members have essential knowledge and competencies, as well as they exhibit openness and readiness towards solving problems or any doubts.”

Fast, professional and timely assistance in the statistical analysis of the material for statutory work, carried out at the Institute of Cardiology in Warsaw. It was also important to prepare the results transparently and understandably for everyone. I can recommend the company with full confidence.

We have worked with BioStat company for over two years now and we mostly deal with clinical trials. They have created an e-CRF system that meets our research requirements as far as maintenance and system administration is concerned. The BioStat company perform their tasks reliably and in due time.

„The quality of IT solutions provided by BioStat exceeds the majority of alternative eCRF systems as far as their functionality and safety are concerned. I express recognition for the terminable and professional organisation of any task commissioned. We recommend the BioStat company services to all entities working in the R&D sector.”

„The BioStat company performed their tasks professionally and always on time. The technical and logistic solutions always meet our substantial meetings and are intuitive for a system user. Any doubts or concerns are explained on an on-going basis without wasting time.”

„The company brought along expertise that involved selecting and using appropriate statistical methods as well as clear and precise writing. The were a reliable and professional partners at all phases of our collaboration.”

“I highly appreciate the knowledge, substantive foundations and, above all, the availability of the BioStat team. You could always count on an explanation of incomprehensible statistical knowledge, a simple translation of the results of statistical tests into practical knowledge and necessary for use in clinical practice. The great graphical help was appreciated.”

„The BioStat company carried out their tasks reliably and in a timely manner, demonstrating high professionalism and providing a complete report with results and statistical analysis. The research was conducted in accordance with the programme schedule as well as with diligence. The final report was designed in a clear and comprehensible way, in compliance with commissioning party’s needs.”

It should be emphasized that the service was performed reliably and professionally. Employees involved in the implementation of the service demonstrated extensive knowledge and experience in the field of statistics and data analysis. During the cooperation, they showed punctuality, patience and conscientiousness. Services provided by BioStat are characterized by a high level of workmanship. We strongly recommend cooperation with BioStat.

"I confirm that the BioStat company has carried out research as part of the project: "The role, position and scope of functioning of Works Councils in the Polish labor relations system". The service was carried out in accordance with the schedule specified in the contract and with due diligence, professionalism and commitment. Taking into account the cooperation with BioStat so far, it should be said that the company is worth recommending.”

“On behalf of the Department of Maritime and Hyperbaric Medicine of the Military Institute of Medicine, I hereby have the pleasure of providing references to BioStat Sp. z o.o., which professionally undertook to develop an advanced tool using the principles of Bayesian statistics (...). The project was completed on time, and the cooperation was harmonious and smooth.”

We highly recommend Biostat Sp. Z o.o. as a reliable and dependable partner. Having already conducted five studies together since 2019, both in direct and indirect collaboration, we are already considering a pipeline of studies for the future. We are very happy with the readiness to implement our research ideas, with diligent execution of statistical assessments and report writing which helped us to bring products to the market.

Software dedicated to pharmacy,
biomedicine and clinical medicine

eCRF.biz^TM is complementing professional statistical
analysis services. By using this system, all of the data is
stored within a single database, making it easier to
control its quality and to monitor the progress of the
entire project.

Software dedicated to pharmacy,
biomedicine and clinical medicine

The eTMF- electronic Trial Master File is a programme/software
that allows the creation, maintenance, collection,
tracking of changes and archiving of the clinical trial master file.
The eTMF stores collections of documents in a structured manner
that allows for evaluation of the progress and quality of data collection.

Portal and telemedicine software

Convenient, fast and safe medical consultations via
chat, video or phone. Individual online
consultations allow you to consult your health
problems with specialists who will issue
e‑Prescription if needed.

Portal and telemedicine software

Complex software
+150,000 to the survey respondents

SurvGo^TM gives you unlimited possibilities to
create and manage customer opinion surveys.
With a view to improving customer opinion,
satisfaction and loyalty surveys, we have developed
a proprietary platform for conducting
customer satisfaction surveys.

Comprehensive panel with
paid surveys online!

For years, we have been successfully
connecting over 150,000 panelists completing
paid online surveys as well as companies and
institutions looking for reliable opinion polls.

CRO providing a full service
in clinical trials and non-
interventional studies.

We comprehensively support our Partners in innovative
research and development projects, digitization
and optimization of business processes.

Current Studies

CRO services

Our Clients

References

Systems

News

CRO providing a full service in clinical trials and non- interventional studies.

We comprehensively support our Partners in innovative research and development projects, digitization and optimization of business processes.

Current Studies

CRO services

Our Clients

References

Systems

News

CRO providing a full service
in clinical trials and non-
interventional studies.

We comprehensively support our Partners in innovative
research and development projects, digitization
and optimization of business processes.