Countries of Operation
Choose a country
USA USA
Bulgaria Bulgaria
Croatia Croatia
Czech Republic Czech Rep.
Estonia Estonia
Georgia Georgia
Hungary Hungary
Kazakhstan Kazakhstan
Latvia Latvia
Lithuania Lithuania
Moldova Moldova
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
millions
(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
Icon, clinical trials in central & easter europe
Clinical Research Services
Clinical Research Services
  • Capability and Feasibility Assessment
  • Project Management
  • Monitoring Services
Icon, clinical trials in central & easter europe
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, clinical trials in central & easter europe
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
Icon, clinical trials in central & easter europe
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
Icon, clinical trials in central & easter europe
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
Icon, clinical trials in central & easter europe
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
Icon, clinical trials in central & easter europe
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

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