Who are Simbec-Orion Laboratory Services?
Simbec-Orion Laboratory Services is a service of Simbec-Orion providing central laboratory analyses for phase I-IV trials; these services are designed exclusively for the biotech pharmaceutical industry.
Simbec-Orion Laboratory Services supports:
- Biotech and pharma companies
- Other CROs
SIMBEC-ORION LABORATORY SERVICES COMMITMENT
Our combined expertise, experience and investment in infrastructure at Simbec-Orion Laboratory Services provide a service that is:
We are committed to ensuring the prompt analysis and electronic transfer of results, helping our customers make critical decisions in a timely manner.
- Invest in the state of the art equipment to ensure we can deliver on our customer’s needs
- Ensure that we apply the most appropriate analytical methods
- Produce the highest quality data sets for your studies
115,000 CLINICAL CHEMISTRY TESTS are performed at our labs PER WEEK
37% OF SIMBEC-ORION LABORATORY SERVICES EXPERIENCE HAS BEEN WITH NEW CHEMICAL ENTITIES
Simbec-Orion Laboratory Services are experienced in:
- Developing and validating complex assays
- Highly selective and sensitive methods
- Supporting all types of clinical studies
Our dedicated project management staff coordinate the bioanalytical phases of your study and:
- Data management
We can coordinate either with your existing CRO or as part of an integrated study run by Simbec-Orion.
METHOD DEVELOPMENT STRATEGY
The method development team consists of dedicated scientists with 150+ years of combined experience in the bioanalytical and method development fields. They can help you achieve:
- Extremely low LLOQ
- Low sample volume
- Large dynamic ranges
- Analysis of multiple metabolites
- Analysis from various matrices (plasma, serum, CSF, blood, urine, etc.)
- Quick method development for high throughput assays using strict criteria
- Rapid method transfer or adaptations
- Overcome challenges like stability issues and matrix effects
- Methods free of interference from metabolites
We also specialise in the development of biomarker assays such as:
- Flow Cytometry e.g. lymphocyte subset phenotyping and cytokine analysis
- Multiplexing assays
- LC-MS-MS e.g. pharmacodynamic biomarkers
Simbec-Orion Laboratory Services Pathology Expertise
Dedicated pathology support for international clinical trials.
Designed exclusively for the biopharmaceutical industry with over 30 years of consistent, high quality delivery.
Simbec-Orion assigns a dedicated Principal Scientist as part of its service plan, who support trial implementation, review testing and any trial-specific protocol requirements and design a laboratory schedule. These Principal Scientists maintain ongoing communication with the Study Manager until trial completion.
We understand the need for rapid results and are committed to expedited analysis and electronic results transfer (upon authorisation) to ensure our sponsors are able to access their information as quickly as possible.
Our Radioisotopes Laboratory performs radioactivity measurements for human ADME and mass balance studies. Radio- HPLC and LC-MS/MS techniques are then used to investigate metabolite profiles and to assist the identification of putative metabolites.