Clinical Trials
in Poland with
Cromos Pharma

Clinical Trials
in Poland with
Cromos Pharma

locations

Poland is the largest clinical trials market in Central and Eastern Europe.

With high levels of patient recruitment, an established framework for conducting clinical trials, a large population of skilled clinical professionals and a reputation for producing high quality data, Poland remains a key location for International Sponsors. Cromos Pharma has a great experience and has been managing clinical research in Poland since 2015 and opened a permanent office in Warsaw in February 2020.

Main advantages to conduct clinical trials in Poland:
  • Strong track record, over 20 years, of producing high quality data.
  • Large population (38.15 million) in comparison with neighboring countries offers great potential for patient recruitment.
  • Large proportion of treatment-naïve patients in a wide range of therapeutic areas.
  • Patients are eager to participate in clinical trials as a means of accessing novel therapies.
  • Highly skilled, qualified, experienced and motivated investigators and site staff.
  • Large network of specialized medical facilities located around major urban centers.
  • Lower costs – on average 30% less than US – due in part to efficiencies in patient recruitment and comparatively lower salaries and fees.
  • EU member state since 2004.

Cromos Pharma’s Services in Poland:

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

Poland

Warsaw office

Warsaw North Gate Bonifraterska 17, Warsaw, 00-203, Poland

Tel: +48 22 104 0971

Poland Country Profile

Сlinical trials in Poland – Country Profile 2022
CROMOS PHARMA IN POLAND Poland is the largest clinical trials market in Central and Eastern Europe. Cromos Pharma has been managing clinical research in Poland since 2015 and opened a permanent office in Warsaw in February 2020. WHY POLAND? Strong track record, over 20 years, of producing high quality data. Large population (38.15 million...
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INQUIRY@CROMOSPHARMA.COM

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