Biomarkers in Clinical Trials: GCP & Translational Expertise

Biomarkers are an objective and quantifiable measure of a (patho-)physiological process or response to a treatment that helps to develop safer, more effective therapies. Biomarkers can be leveraged across disease areas through early detection of treatment response, and precise patient stratification and drug efficacy evaluation. 

Biomarkers inform on what is happening in the body of a patient and can be correlated with other clinical outcomes like functional rating scales. Insights accelerate personalized medicine, improving trial success rates. 

For example, when monitoring patient response to diabetes treatment, a decrease in HbA1c (hemoglobin A1c) can be used as an indication that blood sugar control is improving. 

Evotec's translational biomarker capabilities span preclinical discovery through GCP-validated clinical analysis within one integrated team. 

Our expertise delivers:

• Elimination of vendor transition risks by progressing assays from exploratory to validated endpoints in the same facility
• Acceleration of regulatory timelines with AIFA-accredited (Agenzia Italiana del Farmaco, identical to the USA-specific CLIA-certification)  labs providing GCP-compliant analysis
• Support of all biomarker types, for target engagement, pharmacodynamic, efficacy, safety, and stratification strategies
• Management of 290,000+ biological samples through validated, GCP-compliant systems

With extensive experience across therapeutic areas, we've identified which strategies succeed and which fail. Our scientist-to-scientist collaboration means your exploratory biomarkers can evolve into GCP-validated clinical endpoints without changing teams or facilities, reducing technical risk and protecting assay consistency through regulatory submissions.

Our integrated approach means a smooth progression from fit-for-purpose qualified and custom-developed assays to GCP-validated analysis of clinical samples for use in regulated conditions. 

Evotec offers a unique platform of innovative proteomics and metabolomics technologies to aid biomarker discovery, validation, and application in clinical settings. 

For non-regulated conditions, our labs have multiple high-sensitivity triple quadrupole mass spectrometers, ion mobility quadrupole time-of-flight mass spectrometers, and automated high-throughput sample processors to enable LC/MS bioanalysis of pre-clinical and clinical samples. 

For regulated conditions, Evotec has GCP-compliant high-sensitivity analysis using immunoassay platforms, including SMCxPRO™ (single molecule counting) and Simoa© (single molecule array), for ultrasensitive biomarker detection, and MSD (meso scale discovery), for the detection of biomarkers in single and multiplex formats.

Evotec combines regulatory-accredited laboratories, specialized scientists, and 25+ years of bioanalytical experience to deliver strategies that meet clinical and regulatory demands. Our end-to-end capabilities eliminate vendor transitions and technical risks. 

Whether you need exploratory biomarkers for Phase I or validated endpoints for pivotal trials, our infrastructure supports programs across all therapeutic areas.

Ready to discuss your clinical trial biomarker needs?

Biomarkers predict drug efficacy, enable early detection of treatment response, and reduce trial failures by identifying the right patient populations and supporting dose optimization and regulatory endpoints.

Evotec offers end-to-end biomarker implementation from preclinical discovery through GCP-validated clinical analysis, supported by 80+ scientists with expertise across multi-omics platforms, machine learning-enhanced analytics, and FDA/AIFA-accredited laboratories. Our collaborative, scientist-to-scientist approach ensures seamless assay translation and regulatory guidance across all trial phases, accelerating drug development and clinical trial success.

Yes. We provide services under both regulated (GLP/GCP-compliant) and non-regulated conditions, maintaining identical quality standards across workflows for clinical trial sample analysis.

Yes. Evotec's assays are GCP-validated and engineered for regulatory translation. Our fit-for-purpose qualified assays progress to full validation, meeting FDA and EMA requirements for use as primary or secondary endpoints in clinical studies.

Platform selection is driven by the required sensitivity, dynamic range, desired analyte(s), and regulatory intent. 

Yes. Our validated system supports 290,000+ biological samples with GXP-compliant handling and CFR21 Part 11-compliant information systems, ensuring sample integrity and data traceability throughout programs.