Global clinical development with cost-efficient execution
Through qualified international CROs, investigators, hospitals, research centers, and clinical-development partners, The Pharmacy Hub can help clients evaluate opportunities to conduct clinical studies in international markets.
What a global program can open up
International research programs can, depending on the study design, geography, regulatory pathway, and patient population, provide access to:
- Lower clinical operating costs
- Competitive investigator fees
- Efficient patient recruitment
- Specialized investigator networks
- Larger eligible patient populations
- Centralized project management
- Faster study initiation in selected jurisdictions
- Cost-effective data generation
Our international clinical-development network may provide materially more cost-efficient study execution than traditional U.S.-only development models, depending on protocol, jurisdiction, patient population, and regulatory requirements.
Make clinical development economically practical
Traditional clinical research can become cost prohibitive.
A global development strategy may allow a client to evaluate:
- Countries with strong investigator infrastructure
- Patient recruitment availability
- Competitive clinical site costs
- Established hospital networks
- Qualified CRO capabilities
- Regulatory timelines
- Logistics
- Data-quality requirements
The goal is not to select the cheapest jurisdiction.
The goal is:
- Quality
- Compliance
- Speed
- Cost efficiency
International programs should be evaluated based on
Eight criteria, weighed together rather than traded against each other.
- Scientific requirements
- Ethical standards
- Investigator quality
- Data integrity
- Applicable GCP principles
- Regulatory acceptability
- Patient safety
- Economics
Compliance with applicable requirements
Clinical-research programs are conducted with appropriate compliance with applicable requirements. Potential references where applicable:
- Good Clinical Practice
- Institutional Review Board / Ethics Committee oversight
- Informed consent
- Patient safety
- Protocol adherence
- Source documentation
- Data integrity
- Safety reporting
- Study monitoring
- Applicable local clinical-trial regulations
