Partner with ARCHIMEDlife – The Precision Diagnostics Partner for Rare Diseases and Specialty Diagnostics
At ARCHIMEDlife, we don’t just test—we enable breakthrough therapy access through scientific precision, digital innovation, and medical excellence (see News and Publication section) fully compliance with any regulatory requirements. As a long-standing diagnostics partner to global orphan drug developers, we empower pharma teams to accelerate development, identify patients faster, and deliver measurable outcomes across the full lifecycle of rare disease programs.
Our Focus Pharma-Sponsored Testing Programs: Rare Disease and Specialty Diagnostics—Beyond Genomics
ARCHIMEDlife is built from the ground up to serve rare and ultra-rare diseases but also targets more common disease such as diabetes with special focus in genetic but also immunology or other autoimmunology diseases. Our integrated diagnostic platform combines:
- Clinical Chemistry/ Biochemistry
- Biomarker and enzyme assays – functional testing
- Genetic confirmatory testing – next-generation sequencing (exome, whole genome) and now empowered with long-read sequencing
- Immunology/ Immunogenecity (e.g. ADA / nAb), cellular and functional testing
Unlike labs that focus solely on sequencing, we deliver a multimodal diagnostic solution, tailored to the specific mechanisms of each indication.
Our Platform: One Workflow, Global Scale
Our proprietary WEBPORTAL, developed fully in-house, is used by over 17,500 physicians in 100+ countries. Fully compliant with ISO 27001 and GDPR. It connects:
- Test ordering and logistics – multilingual
- Result reporting and regulatory dashboards
- Physician onboarding and digital Trackings
- Custom export & compliance documentation
This makes ARCHIMEDlife a true diagnostics infrastructure partner, not just a testing provider.
Our Differentiators for Pharma
✅ End-to-End Services – From assay design and validation to global sample logistics, anonymized data reporting, and regulatory documentation.
✅ In-House Reagent Manufacturing (ARCHImedline) – ISO 13485 certified, IVDR-ready, and able to produce custom kits for rare and emerging programs.
✅ Global Sample Coverage – Receive samples from 100+ countries, coordinated through hubs like MedLab Dubai (MENA region).
✅ Immunogenicity & Biomarker Testing – Rapid pilot setup, high-throughput capability, and full quality compliance (ISO 15189, CAP/CLIA in progress).
✅ Project Management Excellence – Matrix teams (science, logistics, data, project management) with dedicated SPOC and milestone tracking.
Why Pharma Chooses ARCHIMEDlife
- Faster patient identification for rare disease and specialty testing programs
- Assay co-development for e.g. biomarkers, ADA, and LDTs
- Data integrity & regulatory readiness across all markets
- Scientific credibility with a track record of publications and global trials
- Lean, responsive execution without layers of bureaucracy
We collaborate with top-tier pharma innovators — and we’re ready to scale your program next.
Clinical Trial Support
ARCHIMEDlife supports global clinical trials — from biomarker qualification to sample testing and real-time reporting. Our infrastructure enables:
- Rapid assay onboarding
- Clinical site onboarding via WEBPORTAL
- Global kit shipment and sample reception
- Centralized, ISO 15189-accredited testing
- Anonymized and audit-ready data delivery
- Ongoing compliance and deviation tracking
Whether for prospective screening, stratified patient inclusion, or immunogenicity follow-up, we act as an integrated diagnostics partner to your clinical development team.
Step-by-Step: How Pharma Works with ARCHIMEDlife
Working with ARCHIMEDlife is streamlined, transparent, and designed to reduce complexity in rare disease diagnostics, screening, and clinical trial workflows.
Whether you need support for patient identification, biomarker validation, or immunogenicity monitoring, our end-to-end diagnostic infrastructure is ready to scale with your program.
| Step | Phase | Description |
| 1️⃣ | Intro & Scoping | Meet our pharma team to define disease area, testing goals, sample volume, and regions. |
| 2️⃣ | Proposal & Feasibility | Receive a tailored proposal: assay menu, timelines, logistics, data output, and compliance. |
| 3️⃣ | Assay Setup & Validation | In-house team customizes or validates assays (biochemical, genetic, ADA, nAb). |
| 4️⃣ | Kit Production & WEBPORTAL Onboarding | AML produces IVDR-compliant kits, configures user access, and trains clinical sites. |
| 5️⃣ | Program Launch (Go-Live) | Sample logistics activated globally; chain-of-custody and tracking managed via WEBPORTAL. |
| 6️⃣ | Result Reporting & Data Delivery | Site- and patient-level results delivered approved formats; real-time dashboards. |
| 7️⃣ | Ongoing QA & Support | Scientific support, project updates, deviation tracking, audit prep, and final reporting. |
✅ Standard project onboarding time: 4–8 weeks
✅ Scalable from 10 to >10,000+ patients globally
✅ Fully aligned with ISO 15189, ISO 27001, IVDR, and other frameworks
How We Work: Our Pharma Project Management Structure
| Function | Role in Project Execution |
| Project Manager (SPOC) | Single point of contact for timelines, coordination, and documentation. |
| Scientific Lead | Biomarker strategy, assay design, and expert result interpretation. |
| Laboratory Operations | Sample processing, test execution, and QC/QA workflows. |
| Data Management | Structured data delivery, anonymization, and sponsor dashboards. |
| Regulatory & QA | Compliance with ISO, IVDR, and clinical SOPs; audit support. |
| Logistics & Supply Chain | Kit production (via ARCHImedline), customs, and global tracking. |
| IT & WEBPORTAL | Secure platform access, onboarding, digital reporting infrastructure. |
All projects follow a milestone-based structure, with flexible setup for pilot programs, prospective screening, or integration into interventional studies.
Ready to collaborate?
Whether you’re launching a screening initiative, validating a novel biomarker, or scaling a global clinical trial — ARCHIMEDlife provides the diagnostics backbone your rare disease program deserves.
Contact our pharma team today: pharma@archimedlife.com