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

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Systems

News

Biostat once again recognized in the Forbes ranking Biostat once again recognized in the Forbes ranking
For another year in a row, Biostat Research and Development Center has been recognized in the ranking of the most dyn...
21 May 2024
Biostat and MSD Polska collaborate on lung cancer study Biostat and MSD Polska collaborate on lung cancer study
The Biostat Research and Development Centre starts cooperation with the MSD Polska pharmaceutical company.  ...
16 May 2024
Post-stroke aphasia. Biostat in a clinical trial in the US Post-stroke aphasia. Biostat in a clinical trial in the US
Biostat's Research and Development Center has prepared a randomization system for a clinical trial being conducte...
15 February 2024
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