Countries of Operation: USA

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USA USA
Bulgaria Bulgaria
Croatia Croatia
Czech Republic Czech Rep.
Estonia Estonia
Georgia Georgia
Hungary Hungary
Kazakhstan Kazakhstan
Latvia Latvia
Lithuania Lithuania
Moldova Moldova
Portugal Office | Cromos Pharma Portugal
Poland Poland
Romania Romania
Serbia Serbia
Slovak Republic Slovak Rep.
Slovenia Slovenia
Türkiye Türkiye
Ukraine Ukraine

The United States remains an unequivocal leader and trendsetter in clinical research

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.

USA Quick Facts
2.6
doctors
(2019)
per 1 000 population
2.8
hospital beds
(2019)
per 1 000 population
335.9
million
(2023)
Total population
9060
initiated clinical trials
in 2022
79.1
years
(2023)
Life expectancy
Main advantages of conducting clinical trials in the United States:
  • Thousands of qualified and experienced investigators
  • Strong track record of producing high-quality research data
  • Established and robust regulatory system
  • Highly professional clinical research culture
  • Access to the largest pharmaceutical market in the world
  • Ethnically diverse patient population
  • Advanced healthcare system
  • Vast number of scientific societies supporting clinical trials
  • Progressive standards of care and cutting-edge diagnostics capabilities

Cromos Pharma’s Services in the United States:

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
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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
Icon, clinical trials in central & easter europe
Independent
Audits
Independent Audits
  • Clinical site GCP audits
  • Documentary Trial Master File audits
  • System Vendor Audits
  • Regulatory Inspection and Sponsor’s audit readiness check

United States

US Headquarters

US Bancorp Tower, 111 S.W. Fifth Avenue, Suite 3150, Portland, Oregon, 97204, USA

Tel: +1 503 894 6091

TO FIND OUT MORE

INQUIRY@CROMOSPHARMA.COM

more countries

USA
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

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

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
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
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.

Georgia
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.

Hungary
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.

Kazakhstan
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
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

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
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.

Cromos Pharma's operations in Portugal
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
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

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
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.  

Slovak_Republic
The Slovak Republic

The Slovak Republic’s health system has clear advantages for clinical trials conduct. The state is fully compliant with EU directives and conducts clinical trials in accordance with EMA’s regulations. The country’s centralized healthcare system allows for seamless management and communication and the cost of clinical trials is significantly lower than in Western Europe.

Slovenia
Slovenia

Slovenia traditionally has a short start-up period, so it is a beneficial landscape to speed up patient recruitment. Slovenia has a network of public and private healthcare providers, research sites in the country are well-equipped and the medical staff is highly motivated. European Union directives are incorporated into Slovenian legislation.

Türkiye
Türkiye

With a population of over 85 million, a well-developed universal healthcare system, a relatively low per capita number of clinical trials, and a large pool of treatment-naive patients, Türkiye is a hidden gem in clinical research. In fact, the number of biotech and pharma companies that are getting engaged in Türkiye has been on the rise, with the  number of clinical trials doubling there for the last 3 years. Over the past two decades the country has steadily worked its way to establishing a strong reputation in the clinical trials segment. Today, these efforts are coming to fruition, as evidenced by the rising number of international companies looking at Türkiye for their next trials.