Simbec-Orion
Global contract research organisation (CRO) with nearly five decades of experience delivering full-service clinical development solutions. Focus areas include early- to late-phase clinical trials, clinical pharmacology, central laboratory and bioanalytical services, and specialist expertise in oncology and rare diseases. Operates integrated teams for regulatory support, investigational product management and site-based trial delivery across international markets.
Industries
Nr. of Employees
large (251-1000)
Simbec-Orion
Pentrebach, Wales, United Kingdom
Products
Central Laboratory
Partnerships with a trusted, local, innovative central laboratory network supporting specialised cell-based assay technology and additional capabilities including Flow Cytometry, Next Gen sequencing, PCR, Genomics, Immunohistochemistry and in situ hybridisation.
Central Laboratory Service
A tailor-made central laboratory service solution for biotech and pharma companies, as well as other CROs, providing rapid clinical trial testing and acting as the central laboratory for clinical development studies.
Central Laboratory Support Services (CLSS)
Dedicated team developing, implementing, and monitoring the sample management plan for clinical trials, adaptable, scalable, and cost conscious in design.
Clinical Trial Safety Testing
Clinical trial safety testing for early to late-phase clinical trials with a full range of instrumentation and bespoke assay panels, supported by a Laboratory Information Management System (LIMS) designed for clinical trials and pharmaceutical research.
MHRA-accredited Clinical Pharmacology Unit
A purpose-built facility for early phase studies including multiple inhaled delivery types such as pressurised metered dose inhalers (pMDIs), dry powder inhalers (DPIs), and nebulisers, with on-site spirometry capability, IMP management, and central laboratories.
Roche Cobas® Pro analyser
A state-of-the-art modular system consisting of clinical chemistry and immunoassay modules, fully integrated with Simbec-Orion's LIMS, capable of processing up to 4,000 clinical chemistry and immunochemistry tests per hour in various matrices including serum, plasma, urine, CSF, and whole blood.
Central Laboratory
Partnerships with a trusted, local, innovative central laboratory network supporting specialised cell-based assay technology and additional capabilities including Flow Cytometry, Next Gen sequencing, PCR, Genomics, Immunohistochemistry and in situ hybridisation.
Central Laboratory Service
A tailor-made central laboratory service solution for biotech and pharma companies, as well as other CROs, providing rapid clinical trial testing and acting as the central laboratory for clinical development studies.
Central Laboratory Support Services (CLSS)
Dedicated team developing, implementing, and monitoring the sample management plan for clinical trials, adaptable, scalable, and cost conscious in design.
Clinical Trial Safety Testing
Clinical trial safety testing for early to late-phase clinical trials with a full range of instrumentation and bespoke assay panels, supported by a Laboratory Information Management System (LIMS) designed for clinical trials and pharmaceutical research.
MHRA-accredited Clinical Pharmacology Unit
A purpose-built facility for early phase studies including multiple inhaled delivery types such as pressurised metered dose inhalers (pMDIs), dry powder inhalers (DPIs), and nebulisers, with on-site spirometry capability, IMP management, and central laboratories.
Roche Cobas® Pro analyser
A state-of-the-art modular system consisting of clinical chemistry and immunoassay modules, fully integrated with Simbec-Orion's LIMS, capable of processing up to 4,000 clinical chemistry and immunochemistry tests per hour in various matrices including serum, plasma, urine, CSF, and whole blood.
Services
End-to-end operational management of clinical trials across phases, tailored to project requirements.
Conduct of clinical pharmacology studies including PK, food effect and drug–drug interaction studies at a dedicated facility.
Routine safety testing, bioanalytical assays and biomarker analysis services to support clinical development programmes.
Clinical data management, statistical planning, analysis and regulatory reporting for clinical trials.
End-to-end IMP supply, storage, distribution and regulatory support for international importation.
Implementation and use of electronic quality, trial master file and clinical trial management systems to support compliance and trial execution.
End-to-end operational management of clinical trials across phases, tailored to project requirements.
Conduct of clinical pharmacology studies including PK, food effect and drug–drug interaction studies at a dedicated facility.
Routine safety testing, bioanalytical assays and biomarker analysis services to support clinical development programmes.
Clinical data management, statistical planning, analysis and regulatory reporting for clinical trials.
End-to-end IMP supply, storage, distribution and regulatory support for international importation.
Implementation and use of electronic quality, trial master file and clinical trial management systems to support compliance and trial execution.
Expertise Areas
- Clinical trial management (Phase I–IV and post-marketing)
- Early-phase clinical pharmacology and PK/PD
- Oncology clinical development
- Rare disease clinical development
Key Technologies
- Multiplex immunoassays
- Bioanalytical assay development and quantification
- PK/PD analysis and clinical pharmacology methods
- Electronic Trial Master File (eTMF) and Clinical Trial Management Systems (CTMS)
News & Updates
Participation in the ASCO 2024 conference and engagement on oncology development topics.
Event participation: Outsourcing Clinical Trials Europe 2025.
Event participation in a regional life sciences conference focused on engagement with industry and research stakeholders.
Presence at BIO Europe 2024 and related networking and business development activities.
Participation in OCT Nordics to engage on topics related to oncology clinical trials in the Nordic region.
Webinar and guidance on benefits of early proactive engagement with regulators to support clinical development planning.
Participation in the ASCO 2024 conference and engagement on oncology development topics.
Event participation: Outsourcing Clinical Trials Europe 2025.
Event participation in a regional life sciences conference focused on engagement with industry and research stakeholders.
Presence at BIO Europe 2024 and related networking and business development activities.
Participation in OCT Nordics to engage on topics related to oncology clinical trials in the Nordic region.
Webinar and guidance on benefits of early proactive engagement with regulators to support clinical development planning.