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

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

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years of business
and scientific experience
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projects conducted within
our professional service
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indications

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employees including engineers,
analysts, biotechnologist,
managers, IT innovators
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collaboration with Polish
and international Sponsors

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publications with
Biostat assistance
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patients
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consulting services

Current Studies

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CRO services

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

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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

Clinical investigation - medical devices

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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
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  • 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
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eCRF

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

Our Clients

References

quote

Systems

News

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Biostat's Research and Development Center has prepared a randomization system for a clinical trial being conducte...
15 February 2024
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  It's been a good year! Summary of 2023 at Biostat We summarize 2023 at Biostat Group. We ...
12 February 2024
ViciData and Biostat project with the support of a Norwegian funds ViciData and Biostat project with the support of a Norwegian funds
ViciData and Biostat are developing Digital Twin technology. Their joint project “Digital Twin of the Eye&rdquo...
06 November 2023
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