Study Sample Analysis – Precise Evaluations for Your Projects
We support you in the analysis and evaluation of samples from clinical studies, validation projects, or research activities — fast, ISO 13485-compliant, and fully aligned with your protocols. As part of our broader immuno service offering, which also includes the development of Immunoassays and Functional Bioassays, we provide structured, reliable, and IVDR-compliant study sample analysis.
We ensure the highest data quality, transparent documentation, and on-time results — even for large sample volumes and complex project requirements.
Study Sample Analysis: Our Services at a Glance
- Sample measurement in validated assays (ELISA, LIA, LFA, cell based assays)
- Batch and single-sample analyses under controlled conditions
- Evaluation based on defined criteria, including plausibility checks and quality control
- Detailed result reports including raw data, graphs, and statistical evaluation
- Optional: Integration into regulatory study documentation
Your Benefits with ASKA's Study Sample Analysis
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ISO 13485 accredited – Ensures full adherence to international quality standards and IVDR requirements.
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Broad methodological spectrum – immunoassays, bioassays, and special formats
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Standardized processes – for reproducible and reliable results
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Fast turnaround times – enabled by our well-coordinated laboratory team
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Customized analysis – tailored to your requirements
Your Study in Good Hands – We Handle the Analysis!
Do you need precise analyses of study samples or want to outsource the evaluation of a validation project? Then contact us. Our experienced team will process your samples quickly, reliably, and according to your specifications – including evaluation, quality control, and comprehensive reporting to the highest standards.
FAQ – Frequently Asked Questions about Study Sample Analysis
What types of study samples do you analyze?
We support preclinical and clinical studies (Phase I–III). Our expertise covers Pharmacokinetics (PK), Pharmacodynamics (PD), Immunogenicity testing (Anti-Drug Antibodies, ADA), and Biomarker analysis.
What is your sample processing throughput?
We offer high-throughput capabilities. Using automated platforms, we can process up to 500 samples per day per run, ensuring rapid turnaround times for large study cohorts.
How is data reporting and analysis handled?
You receive comprehensive reporting packages including raw data, biostatistical evaluation, and final study reports. Delivery formats (PDF, Excel, LIMS-compatible) are fully customizable to your data management plan.
Is your analysis suitable for regulatory submissions (IVDR/ISO)?
Yes. All analyses are performed under our ISO 13485:2016 certified quality management system in Germany. We ensure full traceability and validation documentation required for regulatory submissions and IVDR compliance.
Which assay platforms do you use for sample analysis?
We utilize a broad range of validated platforms including ELISA (Sandwich/Competitive), Lateral Flow Assays (LFA), CLIA/LIA, and bead-based multiplex assays to match the sensitivity needs of your study.