Countries of Operation: Italy

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Italy is a leading European clinical research destination with advanced medical expertise and a strong network of specialized research centers

With a population of approximately 59 million, a universal healthcare system, and an extensive network of specialized research institutions, Italy is a key destination for clinical research within the European Union. The country combines advanced medical expertise, experienced investigators, and 54 recognized research institutions (IRCCS), offering strong capabilities in oncology, rare diseases, and innovative therapies. Supported by a regulatory framework overseen by AIFA and aligned with the EU Clinical Trials Regulation, Italy recorded 838 clinical trial applications in 2025, reflecting continued research activity. As an AIFA-certified CRO, Cromos Pharma helps sponsors navigate local regulatory requirements, access established clinical research networks, and ensure efficient study start-up, patient recruitment, and high-quality trial execution.

5.4
doctors
(2023)
per 1 000 population
3.0
hospital beds
(2023)
per 1 000 population
58.9
million
(2025)
Total population
838
initiated clinical trials
in 2025
84.1
years
(2024)
Life expectancy
Main advantages of conducting clinical trials in Italy:
  • Extensive network of university hospitals and 54 specialized IRCCS research institutions
  • Experienced investigators and established clinical research teams
  • Strong expertise in oncology, hematology, rare diseases, neurology, and cardiovascular research
  • Advanced diagnostic facilities and capabilities for biomarker-driven studies
  • Access to specialized patient populations through established referral networks
  • Growing opportunities for Phase I and early-stage clinical research
  • Strong participation in international and industry-sponsored clinical trials
  • Established regulatory framework aligned with EU Clinical Trials Regulation
  • Specialized infrastructure supporting cell and gene therapies and other innovative treatments
  • Opportunities for multinational clinical trial coordination across the EU

Cromos Pharma’s Services in Italy:

What we do

Icon, clinical trials in central & easter europe
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
icon - eu legal services
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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We are excited to connect with you, understand your goals, and explore how we can support your needs.

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more countries

United States

With a population of over 330 million, a well-developed medical infrastructure, an ethnically diverse patient population, and the largest concentration of biotechnology and pharma companies, the United States remains the unequivocal leader and trendsetter in clinical research. Therefore, it is not surprising that half of the world’s clinical trials are conducted in the United States. In addition to the agile regulatory framework with fast initiation timelines, world-leading scientific minds, and high-quality clinical trial data, inclusion of US clinical sites is essential for drug registration with the FDA. Cromos Pharma has a strong track record of conducting clinical research in the US since 2018. Additionally, the company has a unique advantage of offering a balanced approach of including both US and ex-US clinical sites that helps accelerate recruitment and saves time and resources.

Bulgaria

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.   

Croatia

Croatia provides a natural conduit between EU and non-EU countries, providing an advantage of the Croatian language which is easily understood by the non-EU countries surrounding it. Croatia has a rich heritage in terms of science and good experience in clinical research. As a result, many contract research organizations (CROs) chose Croatia  to conduct clinical trials.

Czech Republic

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.

Estonia

The healthcare sector in Estonia is developing fast. The government of Estonia is constantly working to improve the clinical research environment in the country. The number of study centers has grown and the annual number of submitted clinical trial protocols have steadily increased over the last two decades.

France

With a population of over 68 million, a universal healthcare system, and one of Europe’s strongest public research infrastructures, France is a key destination for clinical research within the European Union. The country combines academic excellence, centralized healthcare data systems, and strong governmental support for innovation. Supported by a transparent regulatory framework overseen by ANSM and aligned with the EU Clinical Trials Regulation, France has significantly streamlined study start up timelines in recent years. High quality data, experienced investigators, and leading university hospitals make France particularly attractive for oncology, rare disease, and CNS studies. Cromos Pharma supports sponsors in efficiently navigating the French regulatory landscape while leveraging high performing clinical sites to ensure timely execution and reliable results across the EU. 

Georgia

Georgia offers international sponsors significant benefits that include a rapid regulatory approval process, substantial naïve patient populations in a wide range of therapeutic indications, skilled medical personnel, and a conducive economic environment for doing business. Cromos Pharma began conducting clinical research in Georgia in 2013. Since then, our Tbilisi-based operation has grown exponentially, managing numerous successful regional and global studies in a broad range of therapeutic indications.

Germany

With a population of over 84 million, a highly advanced healthcare system, and one of the largest pharmaceutical markets in Europe, Germany is a leading destination for clinical research within the European Union. The country combines strong academic institutions, experienced investigators, and a well established site network with high operational standards. Operating under a transparent regulatory framework aligned with the EU Clinical Trials Regulation, Germany offers predictable approval pathways and reliable study start up processes. The country is particularly strong in oncology, cardiology, immunology, and rare disease research. Cromos Pharma supports sponsors in navigating the German regulatory environment while leveraging high performing clinical sites to ensure efficient study execution and high quality data generation across the EU. 

Hungary

Hungary boasts several key advantages for sponsors considering this country as a destination for their clinical research. Its membership in the EU, high educational standards, recent launch of national programs aimed at developing a strong medical research sector, and general economic initiatives aimed at attracting international investment all position Hungary as an attractive location. Each year approximately 20,000 Hungarian patients participate in clinical trials. Cromos Pharma established its office in Budapest in 2016.

Italy | Cromos Pharma's Countries of operation
Italy

With a population of approximately 59 million, a universal healthcare system, and an extensive network of specialized research institutions, Italy is a key destination for clinical research within the European Union. The country combines advanced medical expertise, experienced investigators, and 54 recognized research institutions (IRCCS), offering strong capabilities in oncology, rare diseases, and innovative therapies. Supported by a regulatory framework overseen by AIFA and aligned with the EU Clinical Trials Regulation, Italy recorded 838 clinical trial applications in 2025, reflecting continued research activity. As an AIFA-certified CRO, Cromos Pharma helps sponsors navigate local regulatory requirements, access established clinical research networks, and ensure efficient study start-up, patient recruitment, and high-quality trial execution.

Kazakhstan

There are many benefits to conducting clinical research in Kazakhstan, its strategic geography being one of them. Kazakhstan is a transcontinental country located between Europe and Central Asia, and its health demographics draw influence from both continents. This is one reason why an increasing number of biopharmaceutical companies are considering Kazakhstan as a venue for conducting clinical research. Cromos Pharma began operations in Kazakhstan in 2017, where it initially conducted phase 3 oncology trials, but since has broadened its scope of services. The company opened a regional office in Almaty in 2021.

Latvia

There has been a stable increase in clinical trials in Latvia over the last 10 years. GCP trainings are well organized by the Medicine Information Centre and all participating investigators are GCP-trained.  Following the European Union accession, Latvia has implemented EU directives 2001/20 and 2005/28, and incorporated GCP guidelines into the national law.

Lithuania

Lithuania offers companies a business model favorable to the conduct of clinical research, which is increasingly recognized by many key players in the sector. To date, more than 90 international biotech and pharma companies, including global players, have chosen Lithuania as a location to conduct their clinical trials.  

Moldova

For a relatively small country the number of clinical trials in Moldova is growing rapidly. All clinical trial sites comply with the national and ICH/GCP standards. Moldova offers fast and effective recruitment and a large pool of a treatment-naïve population.

Portugal

Portugal bridges EU and non-EU regions, leveraging its rich heritage in science and medical expertise. With advanced facilities and a diverse population, it’s a prime location for clinical trials. The country’s integration into the EU ensures compliance and market access, attracting global biotech and pharmaceutical companies. Over the past two decades, Portugal has built a robust clinical trial infrastructure, now recognized as a leading European research center.

Poland

With excellent 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 biopharmaceutical sponsor companies. Cromos Pharma has been conducting clinical research in Poland since 2015 and opened a permanent office in Warsaw in early in 2020.

Romania

Romania has a population of 19.4 million people, which ensures high patient availability. The overall data quality provided by the investigational sites is very high and comparable with that of Western Europe, whereas the monitoring costs and the investigator fees are considerably lower. As the country’s healthcare sector is rapidly growing, more and more sponsors are including Romania in its clinical programs.

Serbia

Over the years, Serbia has become a highly reputable location to conduct clinical research. The country has actively strived towards developing a robust healthcare system and has adopted full GCP compliance. An increasing number of biotechnology and pharmaceutical companies are now willing to envision Serbia as a potential regional hub for their business operations and thus are making significant investments in the Serbian market.