Case Studies

Below are just a few case studies in different aspects of the biomarker work that we carry out for clients. If you have any questions or are interested in other work that we may have done previously that is more closely related to the requirements that you have, please don’t hesitate to contact us.





Biomarker discovery // Bioanalysis, biostatistics // Bioanalysis
A multi-site clinical biomarker study // A clinical biomarker study

CASE STUDY 1:

Biomarker discovery

A client requested a biomarker discovery programme for a particular disease area.

Total Scientific

• worked with the client to design a study that was primarily non-hypothesis driven in nature, but which was targeting those analytes of interest to the client
• advised on processing protocols to reduce bias in clinical sample collection (which was carried out by the client)
• ran the biomarker discovery phase, by providing metabolomic analysis of the clinical samples
• carried out chemometric analysis of the resulting data

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CASE STUDY 2:

Bioanalysis, biostatistics

A client had collected samples from a phase I clinical study designed to test not only safety but also immune responses to a number of different clinical challenges. They required analysis of the biological samples collected, in order to identify patterns of changes in immune biomarkers associated separately with their drug treatment and the challenges given to the patients.

Total Scientific

• carried out a range of uniplex and multiplex analyses on the biological samples
• provided a full statistical analysis of the data, identifying a number of biomarkers suitable for further study in subsequent studies

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CASE STUDY 3:

Bioanalysis

A client requested analysis of two drugs in clinical samples that had already been collected.

Total Scientific

• researched availability of appropriate techniques
• evaluated multiple assays
• selected and validated assays internally for each drug analysed all of clients samples

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CASE STUDY 4:

A multi-site clinical biomarker study

The client requested a multi-site clinical study to test a potential new cardiovascular diagnostic assay.

Total Scientific

• set up four recruitment centres across England and Scotland
• helped develop a specialised protocol designed to test practical issues
• developed a custom electronic CRF for a lifestyle questionnaire & medical records data
• recruited 625 patients in 12 months
• collected blood samples & DNA and organised daily transport to the client
• collected a full cardiovascular phenotype on each patient

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CASE STUDY 5:

A clinical biomarker study

Our client requested a study design and quotation for bespoke collection of samples from patients with a particular cancer.

Total Scientific

• discussed the aims of the project with the client and provided additional options not considered by client initially
• recommended purchasing samples from an existing commercial collection as a first stage of the project

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