Countries of Operation: Bulgaria

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Bulgaria offers great potential for pharmaceutical companies and CROs

Bulgaria ranks top 20 in the world by the number of conducted clinical trials per capita and offers great potential for pharmaceutical companies and CROs alike. With around 12,000 patients enrolled annually Bulgaria is considered one of Europe’s clinical research hubs. Bulgarian Association of Clinical Research (BACR) is advocating for high standards in conducting clinical trials and for full adherence to international requirements. 

 

Bulgaria Quick Facts
4.2
physicians
(2020)
per 1 000 population
6.8
hospital beds
(2022)
per 1 000 population
6.6
million
(2023)
Total population
107
initiated clinical trials
in 2022
75.4
years
(2023)
Life expectancy
Main advantages of conducting clinical trials in Bulgaria:
  • Centralized healthcare system with large specialized medical centers
  • Stable and predictable regulatory environment ensured by harmonization of the national legislation with the EU acquis
  • Highly efficient patient recruitment
  • Competent medical staffs
  • High quality of collected data
  • Well-equipped investigational sites

Cromos Pharma’s Services in Bulgaria:

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

TO FIND OUT MORE

INQUIRY@CROMOSPHARMA.COM

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