We build laboratory information management systems, clinical trial platforms, genomic data tools, and regulatory-compliant software for biotech companies, CROs, and research institutions.
8+ biotech and life sciences platforms delivered | LIMS, Clinical Data, Genomics
Biotech platforms delivered
Regulatory audit ready
Faster data processing
Response time
WHY CODEFLAMME
RESPONSE TIME
< 24h
We reply to every inquiry within one business day with a structured plan.
Industry Challenges
Spreadsheet science, trial data gaps, and genomic scale — the research friction we design against.
Data
Laboratory data captured in Excel spreadsheets is not auditable, not shareable at scale, and not queryable for the cross-study insights that drive research acceleration.
Excel
not auditable or queryable at scale
Trials
Paper-based and legacy eCRF systems create data entry errors, audit trail gaps, and submission delays that cost clinical programmes months and millions of dollars.
Months
lost to audit gaps & entry errors
Genomics
Next-generation sequencing generates terabytes of data per run. Organisations without scalable data pipelines and analysis infrastructure cannot process data fast enough to generate timely insights.
TBs
per sequencing run to process
WHY CODEFLAMME
We know the hesitation. Here's exactly how we're different.
No account managers relaying messages. You're in direct contact with the founder and senior engineers on your project — every sprint, every decision.
The team that scopes your project is the team that ships it. We don't swap engineers mid-project to free them up for someone else.
Your idea and IP are protected from the first real conversation — not after contracts are signed.
Every line of code, every design file, transfers to you on delivery. No licensing, no retained rights, no surprises.
Our Approach
Life sciences software requires an unusually precise intersection of domain knowledge, regulatory understanding, and technical excellence. We begin every engagement with a scientific workflow mapping session — understanding the research process, the data model, and the regulatory context before proposing any solution. We have delivered platforms used in FDA submissions and peer-reviewed research publications.
Solutions We Build
LIMS, clinical trial platforms, and genomic data tools — regulatory-compliant software for research-driven organisations.
8 solutions — scroll to compare what we build for your sector.
Sample tracking, experiment management, instrument integration, result capture, chain of custody, and audit trail for laboratory environments.
Digital experiment documentation, protocol management, data capture, and searchable knowledge base for research teams.
Site management, patient randomisation, adverse event tracking, protocol compliance monitoring, and regulatory reporting for clinical trials.
Electronic case report form design, data entry validation, medical coding integration, and eTMF management for clinical data capture.
NGS data ingestion, bioinformatics pipeline orchestration, variant calling workflows, and results visualisation for genomic research.
Biospecimen tracking, storage management, consent management, and sample request workflows for biobanks and biorepositories.
Automated generation of regulatory documents, eCTD assembly, and submission management for FDA, EMA, and other regulatory agencies.
Cross-study data aggregation, statistical analysis workflows, and visualisation dashboards for multi-site research programmes.
Relevant Services
Research platforms, AI pipelines, and cloud infrastructure for life sciences organisations.
LIMS, ELN, and clinical data management platforms
Genomic analysis pipelines, predictive models, and scientific NLP
Scalable bioinformatics infrastructure and data pipelines
21 CFR Part 11 compliance and data integrity audits
Technology Stack
A pragmatic, battle-tested stack — chosen per project for performance, maintainability, and long-term cost.
LAYERS
06
TOOLS
31
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Compliance
GxP validation, FDA electronic records, and clinical data protection for regulated research.
FDA 21 CFR Part 11 compliant electronic records and electronic signatures — audit trails, access controls, and validation documentation for regulated laboratory systems.
GMP, GLP, and GCP computer system validation (CSV) — IQ/OQ/PQ documentation, validation plans, and validation summary reports.
ICH E6 Good Clinical Practice guideline compliance for clinical trial data management systems and electronic data capture.
Patient data protection compliance for clinical trial platforms handling identifiable or potentially re-identifiable patient data.
Laboratory quality management system support for accredited medical laboratories.
FAQ
Can't find what you need? Talk directly with our team.
Book a Discovery CallLIMS, electronic lab notebooks, clinical trial management systems, eCRF/EDC platforms, genomic data pipelines, biobank management systems, regulatory submission tools, and research analytics platforms.
Related Industries
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