Central Laboratory Services
In the race to market, every day counts for patients and stakeholders. Your research decisions, as well as your milestone achievements, rely on accurate laboratory data. Delivered on time and within budget with efficient clinical trial laboratory services.
Our multi-disciplinary team of experienced laboratory scientists and project managers deliver a tailor-made central laboratory service solution for both biotech and pharma companies, as well as other CROs. As an integrated element of Simbec-Orion, our on-campus location provides rapid clinical trial testing for our clinical pharmacology studies, in addition to acting as the central laboratory for our clinical development studies.
Central Laboratory
Network
In addition to our in-house capabilities, we have established partnerships with a trusted, local, innovative central laboratory network to support a range of specialised cell-based assay technology and additional capabilities:
- Cell analysis & imaging, including Flow Cytometry
- Next Gen sequencing
- PCR
- Genomics
- Immunohistochemistry & in situ hybridisation
Bioanalysis
Simbec-Orion offers pharmacokinetic analysis, including FIH, Bioequivalence, Bioavailability and Drug-Drug interaction studies using LC/MS/MS. Find out more detail about our bioanalytical laboratory services.
The bioanalytical support for your study is directly managed by our highly experienced Principal Scientist, liaising with your clinical, pharmacokinetic, or bioanalytical teams. The same Principal Scientist oversees all aspects of your study from development, validation and study analysis giving consistency throughout the program.
With more than 45 years’ experience, we are experts in developing the most challenging of methods with subsequent validation to the required regulations. If required, our clinical teams are also experienced in the transfer of methodologies from other laboratories.
Safety Testing
The central laboratories at Simbec-Orion provide clinical trial safety testing for early to late-phase clinical trials.
Boasting a full range of instrumentation, our scientists provide both standard and bespoke assay panels, utilising a Laboratory Information Management System (LIMS) designed specifically for the execution of clinical trials and pharmaceutical research. Our clinical trial laboratory services include:
- Biochemistry, including urinalysis
- Haematology & coagulation
- Biomarker Analysis
- COVID-19 Screening
Project Delivery
Planning and execution of central laboratory support, for what can be challenging and complex clinical trial research, is led by a dedicated project management team. By providing fully tailored and customised clinical trial laboratory services, our integrated team structure allows for truly flexible central laboratory facilities. With an expert team and industry-recognised project management tools, we easily adapt to any change in requirements through study progression.
Our laboratory quality management team ensure the collection of quality, integrated data for a successful outcome. Led by highly experienced lab staff, we work closely with project managers and utilise quality systems to secure a robust, right first time approach.
Central Laboratory Services
and Logistics
The increasing complexity in clinical trial planning and analysis requires both experience and adaptability. In the last 5 years we have seen 20% year-on-year growth of study sample logistics requirements necessary for efficient pharmaceutical development.
At Simbec-Orion, we are constantly expanding our central laboratory capacity to match this growth. With the support of our dedicated laboratory project managers, we leverage our extensive experience managing a range of small to large clinical trials, ensuring studies are performed on budget, on time, and within scope.
- Our Sample Management and Logistics team provide the full central laboratory solution, handling complex sample and kit shipping networks across the globe.
- Dedicated Central Laboratory Support Services (CLSS) team for your study, who develop, implement, and monitor the sample management plan. Adaptable, scalable, and cost conscious in design.
- Simbec-Orion provides Central Sample Receipts for all your study samples, controlling the full sample lifestyle process from end to end through our Laboratory Information Management System (LIMS), Clinaxys™.
- Sample transport capabilities to handle all shipment conditions from ambient to dry ice and liquid Nitrogen. All packaging and temperature controlling material can be provided by our trusted courier partners.
- Continuous monitoring of sample logistics, with sample traceability and shipment visibility throughout. Managing a sample inventory in collaboration with receiving laboratories and providing daily expected sample shipment reports.
- Storage capacity for all sample types. On site temperature monitored storage for -20⁰C, -80⁰C and in liquid Nitrogen. Off-site sample storage for long term and back up samples.
- Lean and optimised sample collection supply provision, mitigating errors, minimising queries, and maximising study site efficiency.
Finding the balance
Hear from Tracy Thomas, Head of Laboratory Operations about Simbec-Orion’s expertise in supporting small to mid-sized biotech organisations, and how we ensure that we deliver robust trial data on time, whilst maintaining both data integrity and quality.
What our
Clients Say About Us
The people working at Simbec Orion are dedicated, very professional and they cover all aspects of clinical research. A team will be set up for your project, who will have a strong focus on your study in a very open minded and friendly atmosphere. The studies I have outsourced to Simbec Orion, have been successfully managed and performed. I will use Simbec Orion in the future and I can strongly recommend them to other pharmaceutical companies.
Tina Lidén Mascher, Head of Clinical Operations
Klaria AB
