Contract Research Organization (CRO)
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Overview
Contract research organizations conduct clinical trials, laboratory testing, and research studies on behalf of pharmaceutical, biotech, and medical device companies.
With drug development expensive and outsourcing common, CROs generate revenue of $350,000-$1,200,000+ with 30-50% margins through research contracts.
The business requires scientific staff (PhD, research professionals), laboratory facilities, regulatory compliance expertise (GLP, GCP), and quality systems.
Services include preclinical research studies, clinical trial management, laboratory testing and analysis, data management and biostatistics, regulatory consulting and submission support, and site monitoring.
Revenue through contract fees and per-study pricing.
Success factors include scientific credentials and expertise, regulatory compliance and quality systems, specialized equipment and capabilities, building pharmaceutical and biotech relationships, and industry certifications.
Marketing focuses on pharmaceutical companies, biotech startups, medical device companies, and academic researchers.
With drug development costs high and CRO outsourcing standard in 2025, contract research offers scientific opportunities serving life sciences with deep expertise and regulatory compliance as major barriers.
Required Skills
- Scientific research (PhD level)
- Regulatory compliance (GLP, GCP)
- Laboratory techniques
- Clinical trial management
- Biostatistics and data analysis
- Quality systems
Pros and Cons
Pros
- Pharmaceutical and biotech demand
- High-value research contracts
- Scientific expertise barriers
- Growing biotech and drug development
- Long-term client relationships
Cons
- Very high lab and staff investment
- Complex regulatory compliance
- PhD and expert staff required
- Long sales cycles
- Liability and quality demands
How to Get Started
- Hire scientific staff (PhDs)
- Establish laboratory facilities
- Implement quality systems (GLP/GCP)
- Get regulatory certifications
- Market to pharma and biotech
- Build specialized capabilities
- Develop case studies
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