Technology Engineered for
Life Science
Vervelo builds purpose-built software for pharma, biotech, and medical device companies — clinical trial platforms, regulatory data management, lab information systems, and compliant data infrastructure designed for the demands of regulated science.
21 CFR
Part 11 compliant development
FHIR R4
Native for clinical data exchange
GxP Ready
Validation-aware engineering
HIPAA
Compliant by default across all systems
Industry Challenges
The Problems We Solve
01
Regulatory Complexity
21 CFR Part 11, GxP validation, ICH guidelines, and FDA submission requirements create a compliance burden most software teams aren't equipped to navigate. Non-compliant systems delay approvals and create audit risk.
02
Disconnected Data Silos
Clinical trial data, lab results, biomarker datasets, and regulatory submissions often live in incompatible systems — slowing research timelines and making cross-study analysis nearly impossible.
03
Slow Time-to-Market
Manually intensive data workflows, custom integrations between LIMS, EDC, and EHR systems, and paper-based processes at critical handoff points add months to development and approval timelines.
What We Build
Our Capabilities
Purpose-built solutions designed around the real constraints and requirements of Life Science organisations.
Explore all services →Clinical Trial Data Platforms
Build and integrate EDC systems, CTMS platforms, and data collection tools — purpose-designed for clinical trial workflows with audit trails, subject management, and regulatory submission readiness built in.
LIMS & Lab Data Management
Design laboratory information management systems that track samples, manage workflows, and connect to analytical instruments — with 21 CFR Part 11 compliance and full chain-of-custody documentation.
Regulatory Data Management
Build compliant document management and submission systems aligned with FDA and EMA requirements. We support eCTD preparation, audit trail requirements, and CDISC standards alignment.
Biomarker & Genomics Data Pipelines
Design scalable data pipelines for high-volume genomics, proteomics, and biomarker datasets — supporting real-time analysis, data warehousing, and downstream ML model training.
Pharmacovigilance Systems
Build adverse event reporting platforms and signal detection tools that meet ICH E2B requirements — integrating with regulatory agency gateways and supporting automated MedDRA coding workflows.
GxP Validated Software
Develop and validate software to GxP standards including IQ, OQ, and PQ documentation. We support CSV deliverables, risk assessments, and validation protocols that hold up to regulatory scrutiny.
Use Cases
Who We Work With
Pharmaceutical Companies
Clinical data platforms, regulatory submission tools, and pharmacovigilance systems for mid-to-large pharma organisations running complex multi-phase trials and global regulatory filings.
Biotech & Research Organisations
Lab information systems, biomarker data pipelines, and research data management platforms for early-stage biotech companies moving from discovery into IND-enabling studies.
Medical Device Manufacturers
Post-market surveillance platforms, complaint management systems, and UDI compliance tooling for medical device companies navigating FDA 21 CFR Part 820 and EU MDR requirements.
Contract Research Organisations
Scalable trial management platforms, data integration middleware, and sponsor-facing reporting tools that allow CROs to run multiple studies simultaneously with consistent data quality.
Why Vervelo
Engineering Depth Meets Regulatory Knowledge
Building software in life science is not just a technical challenge — it's a regulatory one. Vervelo engineers understand GxP validation principles, 21 CFR Part 11 audit trail requirements, and CDISC data standards. We don't learn these on your project; we bring them in on day one, keeping your development timeline and your compliance posture intact.
Talk to Our Team21 CFR
Part 11 audit trail and electronic signature support
CDISC
CDASH and SDTM-aware data modelling
GxP Ready
Validation documentation produced as standard
No Hand-offs
Compliance-aware engineers on every engagement
Get Started
Ready to build something that works?
Tell us about your project — requirements, timeline, and constraints — and we'll come back with a concrete plan.
Vervelo is a digital-health software partner blending deep clinical insight with world-class engineering to build tailored, secure, interoperable healthcare platforms.
Benefits of custom software solutions
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You fully own IT consulting and software delivered
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You get a highly personalized solution
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Customize and integrate seamlessly
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On-demand scalability is always possible
