Clinical Trial Support at ARCHIMEDlife
At ARCHIMEDlife, we go beyond diagnostics — we act as a fully integrated diagnostics partner for clinical trials and real-world evidence programs, with a focus on rare and complex diseases.
Our infrastructure is purpose-built for supporting biomarker-driven, precision clinical development across all phases — from exploratory feasibility to post-market monitoring. We combine IVDR-ready proprietary assays, in-house reagent manufacturing, and a global logistics and data framework to support sponsors, CROs, and academic consortia worldwide.
✔ End-to-End Diagnostic Enablement
- Assay Co-Development: Examples are biomarkers, ADA/nAb, enzyme activity, and genetic targets – developed and validated by our in-house scientific team
- Compliant Testing: Accredited under ISO 15189 and ISO 13485; CAP/CLIA roadmap underway for U.S. submission readiness. We support mainly PhI/II/III and post-market.
- Custom Kit Manufacturing: Done via ARCHImedline (Vienna), fully IVDR-aligned and ready for batch-labeled global delivery
- WEBPORTAL Platform: Enables onboarding of trial sites, automated chain-of-custody, sample tracking, and real-time result dashboards
- Multimodal Testing Model: Biochemistry, immunology, and genetics – all integrated per indication for maximal interpretability
- Data Management: Secure, structured, pseudonymized delivery – ready for integration into EDC, RWD registries, and regulatory files. We are fully ISO 27001 certified.
Global Trial Infrastructure
- Geographies supported: >100 countries via Vienna HQ and regional hubs (e.g. MedLab Dubai for MENA, LATAM logistics in rollout)
- Scalability: From pilot studies (n < 50) to global trials (n > 10,000)
- Clinical Sites: Trained via multilingual onboarding (German, English, Arabic, Spanish) with direct physician support
- Use Cases:
- Patient pre-screening for inclusion/exclusion
- Longitudinal safety follow-up (e.g. ADA monitoring)
- Early-phase biomarker discovery
- Companion diagnostic development
Why Sponsors Choose ARCHIMEDlife
- Trusted by many Pharma companies
- Proven experience in sponsor-funded screening programs, immunogenicity, and co-developed companion diagnostics
- Lean structure with matrix project teams for scientific, logistical, and regulatory control
- Fully digital physician engagement & result workflow
At ARCHIMEDlife, diagnostics is not an endpoint — it is an enabler of faster recruitment, cleaner data, and more successful therapeutic development.
Research at ARCHIMEDlife: Advancing Diagnostics Through Science
At ARCHIMEDlife, research is not a side activity — it is embedded in our DNA. Our commitment to scientific excellence is reflected in our consistent contribution to the international medical community, with regular publications in peer-reviewed journals, participation in global research initiatives, and close collaboration with academic and clinical partners across five continents.
We operate three dedicated research groups, each focused on advancing diagnostics in their respective domains:
| Research Group | Core Focus Areas |
| Clinical Chemistry | Novel enzyme & biomarker assays, biochemical algorithm development, QC systems |
| Genetics | NGS panel optimization, rare variant curation, confirmatory workflows, long-read sequencing |
| Immunology | ADA/nAb method development, cell-based and functional assays, immunogenicity monitoring |
Our Research Drives Impact
- Assay Development: From idea to implementation — we translate clinical questions into validated, scalable lab tests
- Diagnostic Innovation: We co-develop new methods with clinicians and pharma partners (e.g. ADA, PEth, LSD panels)
- Test Optimization: We continuously improve turnaround times, accuracy, and clinical usability for high-throughput workflows
- Quality Leadership: We develop our own reference materials and QC tools to support precision medicine at scale
- Global Collaboration: We support physicians, hospitals, and researchers in over 100 countries with study services and scientific consulting
Our published work not only enhances scientific understanding but directly influences diagnostic guidelines and clinical decision-making — making ARCHIMEDlife a trusted voice in the rare and complex disease community.