
Simbec-Orion
Clinical development solutions for rare diseases and oncology, from Phase I through post-marketing.
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Full-service CRO delivering clinical trial management across early to late phases, with specialist expertise in rare diseases and oncology. Headquartered in United Kingdom.
Phases
Indications / Therapeutic Areas
Services
- Phase I Clinical Trials
- Phase II Clinical Trials
- Phase III Clinical Trials
- Phase IV / Post-Marketing
- Clinical Operations
- Clinical Trial Services
- Central Laboratory Services
- Bioanalysis
- Biostatistics & Statistical Programming
- Data Management & eClinical
- Regulatory Affairs
- Medical Writing
- Pharmacovigilance & Drug Safety
- US FDA Regulatory Strategy
- EU EMA Regulatory Strategy
- Oncology Specialty Services
- Immunology & Inflammation Services
- Virology Services
- Ligand-Binding Bioanalysis (Large Molecule)
- Ligand-Binding Bioanalysis (Large Molecule)
- LC-MS Bioanalysis (Small Molecule)
- Microbiology Services
- In Vivo PK / PD Studies
- Immunogenicity Assays (ADA / NAb)
Modalities
Technical specifications & accreditations
Infrastructure
About this organization
Simbec-Orion is a contract research organisation with nearly five decades of experience delivering clinical trial management services. The organisation offers a comprehensive, full-service clinical development portfolio with the agility and structure to respond rapidly to client needs.
Core Services
- Clinical Trial Management: End-to-end clinical development solutions across all phases (Phase I through Phase IV and post-marketing)
- Clinical Pharmacology: First-in-human and Phase 1b/2a proof-of-concept studies, including PK, food effect, and drug-drug interaction studies at a purpose-built facility
- Central Laboratory Support: Routine safety testing, immunoassays, and bioanalytical laboratory services
- Biostatistics & Data Management: Biometrics team providing statistical analysis, planning, and reporting across all clinical phases
- IMP Management: Investigational medicinal product handling across all drug delivery routes
Therapeutic Expertise
Specialist experience in oncology, rare and orphan diseases, respiratory, dermatology, vaccines, and anti-infectives. The organisation positions itself as particularly passionate about rare diseases and oncology.
Operational Model
Structured to serve small and mid-size drug developers with tailor-made, scalable solutions. Global team with centralised leadership and international reach. Approximately 90% of clinical pharmacology work involves Investigational Medicinal Products.
Locations
Headquarters
United Kingdom
Belgium
Belgium
France
France
Hungary
Hungary
Italy
Netherlands
Poland
Serbia
Italy
Netherlands
Poland
Spain
United Kingdom
Serbia
Spain
United Kingdom
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