Life Sciences, Pharma & Genomics

LIMS Development, Clinical Trial Management & Genomics Platform Engineering for Life Sciences

LIMS development for genomics and diagnostic laboratories. Clinical trial management software for multi-site regulatory submissions. Clinical genomics platform development for precision medicine. Regulatory compliance engineering for FDA, EMA, and ICH environments.

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LIMS That Cannot Scale with Genomic Test Volume

Labs moving from single-analyte chemistry tests to NGS panels and whole exome sequencing - running LIMS designed for the former. Sample backlogs, QC failures, and CLIA inspection findings accumulate as test volume and complexity grow.

Clinical Trial Data Fragmented Across Sites

Multi-site trial CRF data in site EDC systems, lab data in sponsor LIMS, biomarker data in genomics platforms - with no central repository for integrated safety and efficacy analysis. Database lock activities take months instead of weeks.

Genomic Data With No Governed Analytics Infrastructure

WGS and WES data accumulating in object storage - VCF files, BAM alignments, clinical annotations in spreadsheets - with no platform that makes it queryable, analytically accessible, or usable for AI model training.

Regulatory Compliance Without Software Validation

GxP systems deployed without IQ/OQ/PQ validation documentation, 21 CFR Part 11-compliant audit trails, or GAMP 5-aligned lifecycle documentation - creating FDA inspection exposure.

01What we build

What We Build for Life Sciences, Pharmaceutical, and Genomics Organizations

Four service areas from LIMS engineering and clinical trial data management through clinical genomics platforms and GxP regulatory compliance.

01
LIMS Development for Genomics & Diagnostic Laboratories

Custom and platform-based LIMS for genomics, molecular diagnostics, and clinical reference labs, built for the sample volumes, assay complexity, instrument interfaces, and regulatory traceability that off-the-shelf LIMS cannot support at scale.

  • Custom LIMS: accessioning, chain-of-custody, order management, QC enforcement, result sign-off, and report generation
  • LabWare, LabVantage, StarLIMS customization: assay-specific modules, Illumina/PacBio/Thermo Fisher instrument interfaces
  • NGS capabilities: library prep tracking, flowcell management, VCF ingestion, and variant result structure support
  • LIMS-to-EHR integration: HL7 ORM/ORU order-result workflow with LOINC-coded results and FHIR DiagnosticReport delivery
Explore LIMS services
02
Clinical Trial Management Software & EDC Integration

Clinical data management systems and EDC integration for multi-site trials, supporting IND, NDA, BLA, and EU CTR submission readiness aligned to ICH E6(R2) GCP.

  • CDMS development: CRF design, data validation rules, query management, and ALCOA-compliant audit trail
  • EDC integration: Medidata Rave, Oracle Clinical, and REDCap API integration for cross-site data harmonization
  • CDISC SDTM and ADaM dataset generation, define.xml, and eCTD submission package preparation for FDA and EMA
  • Biomarker integration: genomic data linked to trial records by subject identifier for biomarker-efficacy analysis
Explore clinical trial services
03
Clinical Genomics Platform Development for Precision Medicine

End-to-end clinical genomics platforms from sample receipt through bioinformatics pipeline execution, variant interpretation, clinical reporting, and FHIR-based EHR delivery.

  • Pipeline integration: WES, WGS, RNA-Seq, and targeted panel pipelines triggered automatically at LIMS accessioning
  • Variant interpretation: ACMG classification workflow, ClinVar/ClinGen/OncoKB integration, and VUS management
  • Clinical reporting: structured PDF reports and FHIR R4 DiagnosticReport delivery to Epic, Cerner, or Athenahealth
  • Pharmacogenomics: CPIC star allele determination, drug-gene CDS alerts, and EHR point-of-prescribing integration
Explore genomics platform services
04
Regulatory Compliance Engineering, FDA, EMA & GxP

Software validation and lifecycle documentation for LIMS, EDC, and clinical trial management systems in FDA-regulated environments, 21 CFR Part 11, GAMP 5, and ISO 13485 aligned.

  • CSV: IQ, OQ, and PQ protocols for LIMS and clinical systems in FDA-regulated GxP environments
  • 21 CFR Part 11: audit trail implementation, electronic signature controls, and access management
  • GAMP 5 lifecycle: URS, FS, DS, Traceability Matrix, and Test Plans per system risk classification
Explore compliance services
02Outcomes

What Life Sciences and Genomics Organizations Get Back

✓
Faster sample-to-report cycle times through LIMS automation and instrument interface integration
✓
Regulatory submission readiness built in from Day 1, not assembled retrospectively before FDA inspection
✓
Precision medicine insights delivered to treating clinicians via FHIR at the point of care
✓
Genomic data consolidated into queryable analytics infrastructure for cohort analysis and AI model training
✓
CLIA and CAP audit trail completeness at genomic data volumes, maintained automatically by the LIMS
✓
Clinical trial database lock timelines reduced through unified multi-site data management
03Case study

Proof From Life Sciences Engagements

ISO 13485 Compliant AI-Powered Wearable
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Frequently Asked Questions

What are the most common LIMS scalability challenges in genomics labs?
Four categories: volume, database and accessioning workflow degradation as throughput scales from hundreds to thousands of samples per day; data complexity, result schemas designed for single-analyte tests that cannot store multi-hundred-gene panel VCF data as queryable structured records; instrument proliferation, each new sequencer requiring a custom interface the LIMS was not designed for; and regulatory traceability, CLIA/CAP audit requirements that the LIMS cannot capture at genomic data volumes. We address all four through targeted LIMS extension and purpose-built genomics modules.
What regulatory requirements apply to clinical trial management software?
21 CFR Part 11 applies when the system creates, modifies, or transmits records FDA requires, requiring audit trails, electronic signatures, access controls, and system validation. ICH E6(R2) GCP requires ALCOA data principles (attributable, legible, contemporaneous, original, accurate) and prospectively documented data validation rules. GAMP 5 provides the validation framework: system categorization, risk-based testing, and a Validation Summary Report certifying the system for its intended use.
How do you integrate a genomics platform with clinical EHR systems for precision medicine delivery?
Three integration layers: LIMS-to-pipeline, accessioning completion triggers automated pipeline job submission with sample metadata and assay parameters; pipeline-to-interpretation, annotated VCF output ingested into the interpretation platform with pre-classification against ClinVar and OncoKB, and case assigned to clinical interpreter; interpretation-to-EHR, completed reports delivered as FHIR R4 DiagnosticReport resources to Epic, Cerner, or Athenahealth, visible in the clinical chart with variant-level detail queryable via FHIR Observation.
What does CSV (IQ/OQ/PQ) require for a LIMS in an FDA-regulated environment?
Installation Qualification (IQ) verifies the system is installed correctly per the specified hardware, software, and network configuration. Operational Qualification (OQ) tests each system function against documented requirements using test scripts with defined expected and actual results. Performance Qualification (PQ) demonstrates consistent performance under representative operational conditions, testing complete end-to-end workflows. All documentation is assembled in a Validation Summary Report, signed by accountable parties, and retained per 21 CFR Part 11 and applicable record retention requirements.
04Related solutions

Explore the Underlying Solutions

EHR, LIMS & Clinical Systems

LIMS development, instrument interfaces, and LIMS-to-EHR integration for diagnostic labs.

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Data Interoperability & Integration

FHIR and HL7 integration for LIMS-to-EHR result delivery and genomics platform connectivity.

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Genomics & Life Sciences Hub

Bioinformatics pipelines, multi-omic analytics, and pharmacogenomics, the full genomics practice.

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Ready to Build the Lab and Clinical Platform Your Life Sciences Programme Needs?

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