Clinical Trials
in Czech Republic with
Cromos Pharma

Clinical Trials
in Czech Republic with
Cromos Pharma

locations

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

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

Main advantages to conduct clinical trials in the Czech Republic:
  • Solid clinical research infrastructure.
  • High density of clinical sites.
  • High standards in education (particularly clinical and medical training).
  • Supportive regulatory framework.
  • Well-organized centralized healthcare system.
  • Large pool of skilled clinical professionals trained in GCP that produces high quality data.
  • Significant treatment-naïve patient populations in a diverse range of therapeutic areas.

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
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
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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Biostatistics
and data
management
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
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
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
Independent Audits
  • Clinical site GCP audits
  • Documentary Trial Master File audits
  • System Vendor Audits
  • Regulatory Inspection and Sponsor’s audit readiness check
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Rare and
Orphan
Diseases
Rare and Orphan Diseases
  • Circumventing recruitment challenges
  • Integrated expertise and support – what does this mean?
  • Active engagement with disease-specific societies and support groups
  • Effective use of referral sites

OUR EXPERIENCE

Over the past 18 years Cromos Pharma has conducted over 300+ clinical trials in a vast range of therapeutic indications. The graphs below represent the last 3 years of this experience.

*Other: Pediatrics, Dermatology / Infectious diseases, Vaccines, Gynecology / Surgery, Trauma / Surgery, General Medicine, Hepatology, Trauma, Nephrology, Musculoskeletal, Hematology, Allergology, Surgery / Anesthesia, Obstetrics / Gynecology, Nutrition

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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INQUIRY@CROMOSPHARMA.COM

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