Clinical Development

Powerful solutions and expertise to drive decisions that translate discoveries into effective cancer therapies and diagnostics

overview

Redefine how you make decisions

Taking novel cancer treatments from bench to bedside requires decisions based on scientific data that balance tradeoffs and risks. In this complex landscape better, not more, information makes breakthroughs. Effectively lead clinical trials and advance clinical pipelines with an expert partner in Tissue Phenomics. Redefine knowledge-driven biomarker analysis with Definiens and seamlessly translate research from clinical knowledge to the next generation of diagnostics.

Decide now.

Mine quantitative tissue analyses, patient outcomes, medical history and other data types to uncover clinically relevant patterns. Tissue Phenomics transforms big data into knowledge that leads to disease insights, novel drug targets and new indications rapidly and reliably.

Be targeted.

Leverage Tissue Phonemics to predict drug responses based on biomarker signatures that distill complex biology into meaningful IHC, ISH and IF assays. Whether in clinical trials or patient care settings, we help you identify patients who will most likely benefit from a therapy.  

Move forward.

Rely on our experts and solutions with quality management system certification to fast-track commercialization of your tissue-based assay. Through development, approval and even if it evolves into a CDx, we work with you to meet requirements and timelines.

services

Clinical Trials

Drive pipeline decisions

Customized analysis of cell status, cell-to-cell dynamics and tissue context of biomarkers unlocks a deeper understanding of cancer. We quantify these features during assay development and the resulting insights drive confident pipeline decisions for clinical trials. Our scientific, regulatory and medical team support you throughout the process. Our services include:

  • Biomarker screening to identify the indication of most impact
  • Evaluation of drug response profiles for pharmacodynamics studies
  • Exploratory studies with custom assays and quantitative readouts to support regulatory filing

Signature Discovery

Discover the best signatures

Assessing the potential of a biomarker to identify patient populations requires correlating patient data with drug responses. Using Tissue Phenomics, we mine data from your tissue samples to find meaningful signatures that link ‘omics data with clinical outcomes and generate insights beyond the scope of other approaches. We offer:

  • Data-rich biomarker readouts from histological slides of any tissue
  • Development and evaluation of the most impactful signature candidates
  • Unique mining of tissue, ‘omics, outcomes, medical history and other data

Companion Diagnostics

Develop precise, market-ready CDx

Certainty is the hallmark of next-generation diagnostics. Our precise quantitative biomarker readouts and best-in-class assay development in accordance with our certified quality management system, build certainty into your CDx. Our scientific and regulatory teams help design the best strategy to advance your prototype to regulatory filing and into the clinic. We support you with:

  • Scientific expertise from board-certified pathologists and top experts in Tissue Phenomics
  • International regulatory knowledge for documentation and interactions with authorities
  • Agile project management in strategy planning and troubleshooting

Experience an engaging and successful partnership

Our services build on transparent collaboration, where a dedicated project team ensures every goal is clear and every need is met. Problems are solved systematically; answers are delivered on time. And where data drives decisions, all project partners can view results in our proprietary VeriTrovaTM collaboration platform.

A new take on immune cells

Insights from immune cell populations involved in anti-tumor defense

Insights from immune cell populations involved in anti-tumor defense

CD8 staining shows the number and distribution of cytotoxic T-lymphocytes within an aggregate of lymphocytes surrounding neoplastic tissue. Many CD8 positive T-lymphocytes in close proximity to the tumor indicate a better prognosis. 

Power your clinical pipeline with Definiens solutions and expertise.

Contact us to find out more about how we accelerate clinical development and catalyze pipeline decisions.

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Deepen your insights for biomarker discovery

Our powerful software solutions advance tissue-based biomarker research&discovery

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Drive patient centered care

Definiens-powered diagnostics make your idea today, the answer of tomorrow

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