Bioanalysis Management

Scientific oversight for your clinical trial bioanalysis

Extending your in-house expertise

Effective bioanalysis management requires more than simply coordinating laboratories. Pharmacokinetic and biomarker sample analysis requires scientific oversight to ensure the right methods, laboratories and processes are in place.

Our experienced team can manage method development and clinical trial sample analysis through our network of pre-qualified partner laboratories, complementing your internal capabilities and reducing the management burden on your team.

Biofortuna colleagues behind a laptop, reviewing requirements and providing expertise
Biofortuna colleague in PPE in the lap, handling clinical samples as part of our end to end service

End-to-end bioanalysis management

We can contract directly with pre-qualified laboratory partners and coordinate bioanalysis on your behalf. This can be particularly valuable for studies involving multiple biomarkers, where three or more specialist laboratories may be involved in a single trial.

Reduced vendor management: we manage relationships with laboratories involved in your study, reducing the vendor management burden on your team.
Expert oversight: our bioanalytical expertise provides scientific oversight of method development and sample analysis, particularly where this specialist knowledge isn’t available in-house.
Single point of contact: you have one point of contact throughout the process, from manual creation through to the analysis report.

Alternatively, if you already have a preferred laboratory, our team can work with them too.

Laboratory qualification

We have a network of pre-qualified laboratory partners covering a range of analytical specialties. Where your study requires a niche capability or you have a preferred laboratory, our team can provide the appropriate qualification oversight.

Our risk-based approach considers the intended use of the resulting data to determine the level of laboratory qualification required.

What we assess

Our laboratory qualification process provides assurance that the laboratory, its people, processes and equipment are appropriate for the work being performed, considering:

Method validation and alignment with relevant FDA and EMA guidelines
Staff training and competency
Instrument maintenance
Laboratory management and quality processes
Good Clinical Laboratory Practice (GCLP)
Sample and data security

This ensures method validations are robust, laboratory processes are appropriately managed and the required standards for sample and data integrity are maintained.

Two Biofortuna colleagues in the lab in PPE, reviewing trial requirements and ensuring laboratory qualification
Biofortuna colleague using a laptop to offer bioanalysis consultancy to customers

Bioanalysis consultancy

From reviewing a validated method to conducting full due diligence for a potential asset purchase, our experienced team provides specialist bioanalytical expertise tailored to your requirements.

Discuss your bioanalysis requirements

Talk to our team about the bioanalytical support you need and how are experts can help your project.

Follow the links below to discover more about our clinical trial support services

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