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Clinical Bioanalysis

Concept Life Sciences' highly experienced scientists provide a consultative approach and bespoke advice on the most appropriate approach for method development based on the complexity of your compounds.

We pride ourselves on quality, transparency, and data integrity, assuring the compliance of your regulatory submissions.

Our team quickly perform method feasibility studies to provide a timely indication of the level of difficulty before any subsequent bespoke method development is performed.

Methods are then developed and validated to an appropriate level. This ranges from scientific validations that are suitable for early stage investigative studies through to full regulatory validations (FDA, EMA) required to support pivotal clinical trials.

A single point of contact seamlessly directs clients through the various studies within a project (method development to sample analysis) and all elements are performed to the highest quality to ensure data integrity.

Each study is performed in accordance with a plan and is documented clearly for ease of inspection. We provide standardised and tailored formal reports for method validation studies and sample analysis projects. Fast, quality assured, interim data can be provided throughout the life-cycle of clinical studies and PK data analysis can be performed for clinical studies that are not involved in regulatory decision making.

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Clinical bioanalytical services

LC-MS/MS Method Feasibility and Development
LC-MS/MS Method Validation (scientific, cross, partial, and full) for pivotal clinical studies performed in accordance with current industry guidelines
Fast turnaround for early Phase I clinical trials
Full support for bioavailability, bioequivalence, and drug-drug interaction studies
PK data analysis (WinNonlin) for clinical studies that are not involved in regulatory decision making

Instrumentation and techniques

Sciex 6500 and Waters TQS Triple Quadrupoles
Sciex QTrap® 6500+ with MRM³ capability for enhanced specificity
Waters GS-XS QTof for High Resolution Accurate Mass
SelexION™ differential ion mobility technology for increased specificity
2D-ExionLC with multi-dimensional chromatography for increased selectivity
On-line radiochemical detection, UV, and GC-MS/FID for analytical support of compounds not amenable to LC-MS/MS
Chiral Chromatography
Metabolite and multi-analyte methodologies
Surrogate peptide approaches in support of large molecule bioanalysis by LC-MS/MS (Proteins, ADCs, etc.)
Oligonucleotide analysis

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