Study Group Profiling
1. Imperacer for Biomarker Profiling:
Biomarkers are widely used by pharmaceutical companies for numerous issues and applications. In the development of clinical studies they do not only identify patients most suitable for a given therapy but they also help to rank disease levels in clinically relevant groups.
Biomarkers can be evaluated as:
- prognistic biomarkers => predict disease outcome without further treatment
- predictive biomarker => foretell response to specific therapy
- pharmacodynamic biomarker => decide upon optimal dose of a drug for individual patient
Depending on the accuracy and sensitivity of the biomarker evaluation, the initial step of a clinical study can be significant up on the level of success.
Biomarker characterization with the ultra sensitive Imperacer® technology helps to improve decision making upon the starting point of clinical studies.
2. Imperacer for patient profiling:
To generate the best preconditions for a successful clinical study, it is important to make sure that patients within the study group are positively tested on the biomarker and therefore improve the likelihood to profit from the tested drug.
Facing the fact that most technologies show decreased sensitivity in ligand binding assays, the bigger part of potential target patients will perish due to detection technologies, which do not show adequate sensitivity.
Ultra sensitive patient profiling with the Imperacer® technology will show you every potential test person for the intended study. You will be able to place the potential test persons into distinct test groups according to their disease profile. Show the base line of the disease marker und you will be able to show that a respond on the drug corresponds with biomarker reduction to base line level.
The Imperacer® patient profiling system will improve the outcome of your preclinical and clinical study. Implement patient profiling prior to study enrolment according to FDA guidance.
3. Imperacer for systematic study enrolment:
- Initial analysis of biomarker and detection capacity
- Assay development optimized and validated for ultra sensitive patient screening
- Testing and rating of individuals for study enrolment test group
- Option for companion diagnostics
Improve drug approval procedure with pre-selected test groups
- Base your decisions upon critical biomarker levels for better drug response
- Distinguish different stages of disease on biomarker level
- Act upon positive reaction on applied drug
Decrease costs for clinical studies
- Via specific engineering of study set up with Imperacer®
Increase positive outcome of clinical studies
- Via perfectly predefined test groups
