Central Laboratory Services

Fully-integrated, or standalone, multi-disciplinary central laboratory services to support your clinical development needs

In the race to market, every day counts for patients and stakeholders. Your 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

 

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. Our clinical trial laboratory services include:

  • Biochemistry, including urinalysis
  • Haematology & coagulation
  • Biomarker Analysis
  • COVID-19 Screening

Bioanalysis

Simbec-Orion offers pharmacokinetic analysis, including FIH, Bioequivalence, Bioavailability and Drug-Drug interaction studies using LC/MS/MS.

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.

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.

Contact a Scientist

 

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.

Our combined skills and depth of expertise allows us to deliver customised analytical solutions, giving each of our clients a personalised, bespoke service most suited to the needs of their development program.

We would be delighted to discuss your needs with you.

Contact a Scientist

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If you think we could be right for you, get in touch.

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