Countries of Operation: Czech Rep.

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The Czech Republic is a highly attractive location to conduct clinical trials

The Czech Republic is a well-established location for clinical trials’ conduct with a strong track record of generating high quality clinical data. In recent years, it has developed a reputation as an attractive location for niche clinical trials including hematologic malignancies, gene and cell therapies, and rare diseases. Cromos Pharma began its operations in the Czech Republic in 2010 and established a representative office in Prague in 2015.

Czech Republic Quick Facts
per 1 000 population
hospital beds
per 1 000 population
Total population
initiated clinical trials
in 2022
Life expectancy
Main advantages of conducting clinical trials in the Czech Republic:
  • Reliable clinical research infrastructure
  • High density of clinical sites
  • High educational standards, particularly in clinical medicine
  • Well-organized centralized healthcare system
  • Supportive regulatory framework
  • Large pool of skilled clinical professionals trained in GCP delivering high quality data
  • Considerable treatment-naïve patient populations in a diverse range of therapeutic indications

Cromos Pharma’s Services in Czech Republic:

What we do

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Patient recruitment
Patient recruitment
  • Promotional and educational materials
  • DTC outreach
  • Investigator’s materials
  • Booster visits
  • Referral sites
  • Commitment to patients
  • Patient’s materials
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Clinical Research Services
Clinical Research Services
  • Capability and Feasibility Assessment
  • Project Management
  • Monitoring Services
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Regulatory Services
  • Compilation of initial documents for RA and ECs/IRBs
  • Review of IC documentation
  • Obtaining of trial subjects’ insurance
  • Secure import/export licenses
  • Regional regulatory consultation
  • Regulatory strategy and clinical development planning
  • Submissions to Regulatory Agencies
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EU legal representation
EU legal representation
  • Your clinical gateway to Europe
  • Legal representation in EU/EEA
  • QP Statement obtainment
  • Cost-effective and time-saving services
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Medical Writing
  • Study concepts and outlines
  • Clinical study protocols and amendments
  • SAP for inclusion into protocol
  • Investigator Brochures
  • Investigational Medicinal Product Dossiers
  • Patient Informed Consent Forms
  • Clinical Study Reports
  • Executive summaries for efficacy or safety, ISS, ISE
  • Reviews of clinical and nonclinical data
  • Patient narratives, SAE narratives
  • Abstracts, posters, and journal articles
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and data
Data Management
  • CRF development/validation
  • Customized database design/validation
  • Data entry screen design/validation
  • Double data entry
  • Programming under SAS
  • Data validation
  • Data listings
  • Convenient data format for the client
  • Data transfers
  • Data coding
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CTM Logitics
  • Full Scope of Clinical Trial Logistics Services
  • Controlled access to storage areas
  • 24/7 receipt of IMP and CTM
  • Patented warehouse database program
  • General liability and property insurances
  • Compliance with ISO 9001:2015 & GDP
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PV Support
  • Therapeutic, technical, and operational excellence
  • Tailored and cost-effective safety solutions
  • Flexible outsourcing of safety functions
  • A team of QPPVs for registered products in EU
  • Updated country-specific regulatory requirements
  • Robust quality system
  • Pharmacovigilance consultancy
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Independent Audits
  • Clinical site GCP audits
  • Documentary Trial Master File audits
  • System Vendor Audits
  • Regulatory Inspection and Sponsor’s audit readiness check

Czech Republic

Czech Republic office

Nove Butovice, building C, 4th floor, Bucharova 2657/12, Prague, 158 00, Czech Republic

Tel: +48 22 104 0971

Czech Republic Country Profile

Сlinical trials in the Czech Republic – Country Profile 2022
CROMOS PHARMA IN THE CZECH REPUBLIC Cromos Pharma began working in the Czech Republic in 2010 and established a representative office in Prague in 2015. BACKGROUND The Czech Republic is a high-income country with a population of 10.69 million and a GDP of $245.33 billion (World Bank, 2020). Its largest city and capital is...
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