Services

Our Insights redefine biomarker programs

Leverage your biomarker data seamlessly from early research into next generation clinical diagnostics.

Develop impactful and robust biomarkers from early research through late clinical

Harmonize & apply trial data beyond single trials

Free resources in your organization

Insights Services

Modular or customized Biomarker Profiling and Data-Mining interpreted by a unique team of scientists, biostatisticians, clinicians & pathologists 

- Identify predictive signatures & develop responder / non-responder hypothesis
- Increase probability of successful pipeline projects
- Expedite a validated predictive signature from clinical trial assays through CDx Bring second generation AI (Artificial Intelligence)-enhanced image analysis solutions into your programs

Consulting

Expert support for your biomarker strategy, clinical trial design and CDx market access.

- Identify & qualify the right laboratory & IVD partner for tissue based assays
- Include regulatory compliant services along the way from inception through roll-out
- Setup a robust biomarker program & lab-assay strategy

insights.definiens.com

The web-based Definiens Insights Portal enhances collaboration with internal and external stakeholders, secure data-access and -governance.

- Easily exchange biomarker and pathology image-data with CROs, laboratories, trial sites and Definiens experts
- Reduce time to Biological Insights through worldwide access of all project relevant data in real time
- Apply data governance across trials and use a central data repository that complies with strict security & data-safety standards
- Generate automatic audit trails and be certain of early compliance when moving into pivotal admission trials

Regulatory Services

Definiens regulatory expertise addresses changing regulatory requirements

- Definiens regulatory consulting experts support your program towards your desired endpoint (i.g. GcP-compliant CTA with IDE; Single-site PMA or IVD)
- Modular pre-developed components are designed for fast transition from component verification through full analytical system validation
- Definiens customized digital image analysis solutions can be developed under design control to your needs
- The “Definiens Insights”-portal offers robust audit trails at your demand

Speed up and align your IO-stratification abilities across your pipeline with the Definiens IO-Panel

Contact us to find out more about how we accelearte IO Biomarker Programs with next generation insights.

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Standardize your biomarker approach

Definiens' IO-Panel speeds up and aligns your IO-stratification abilities across your pipeline

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Access research resources and clinical trial projects worldwide

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Get acquainted with the Definiens team, news and vision

Explore all that Definiens has to offer, including technology, thought leadership and career opportunities.

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