Talk to us about your biotech software project.
Tell us your laboratory workflows, your regulatory obligations, and where your current systems create compliance risk or research inefficiency. We'll scope the right platform and give you a fixed cost.
Biotech Software Development
Custom software for biotech companies, CROs, and research organisations whose laboratory workflows, data volumes, and regulatory obligations require more than generic LIMS platforms or spreadsheet-based tracking can deliver.
Built with regulatory compliance designed in from the start -- audit trails, electronic signatures, data integrity controls, and the validation documentation FDA and EMA inspectors expect -- not retrofitted after the platform is built.
LIMS with sample lifecycle management, instrument integration, and audit-ready data capture
Electronic lab notebooks replacing paper records with structured, searchable, 21 CFR Part 11 compliant data
Clinical trial data management -- protocol tracking, subject management, AE reporting, and regulatory submissions
Bioinformatics pipelines for genomics, proteomics, and next-generation sequencing data processing
RaftLabs builds custom biotech and life sciences software for companies that need more than generic platforms. We build LIMS, clinical trial data management, bioinformatics pipelines, electronic lab notebooks, FDA 21 CFR Part 11 compliant systems, genomics data platforms, and regulatory submission tools. Most projects ship in 14 to 20 weeks at a fixed cost with full source code ownership.
- Products shipped
- 100+
- Industries served
- 24+
- Cost delivery
- Fixed
- Week delivery cycles
- 14-20
Regulatory compliance is not a feature you add later in life sciences software
Biotech and life sciences software operates under regulatory frameworks -- FDA 21 CFR Part 11, EU Annex 11, GxP guidelines -- that require audit trails, electronic signatures, access controls, and data integrity protections to be built into the system architecture from the start. Platforms built without these controls and later validated for regulatory use are expensive to retrofit and create ongoing validation burden every time a change is made.
We build life sciences software with the compliance architecture in place from the first sprint. The audit trail captures every data creation, modification, and deletion event with user identity and timestamp. Electronic signatures meet the definition under 21 CFR Part 11. Access controls are role-based and documented. The validation approach -- IQ, OQ, PQ documentation -- is scoped at the start of the project so the system is inspection-ready when it goes live.
Problems we solve in biotech
- 01
Your research data lives across instrument exports, shared drives, and spreadsheets with no audit trail showing who changed what
When a scientist needs to reconstruct the provenance of a result -- which instrument produced the raw data, who reviewed it, what version of the method was in use -- that investigation spans four systems and takes hours. For an FDA inspection, that reconstruction has to be immediate and complete. A LIMS that captures instrument output, review actions, and method versions in a single record with an immutable audit trail makes that provenance available in seconds, not hours.
- 02
Regulatory submission preparation takes six to eight weeks because study data was never structured for submission from the start
When clinical or analytical data is collected in formats that made sense for the study but not for submission -- free-text fields where coded values are required, patient identifiers where anonymisation is needed, result formats that don't map to CDISC SDTM -- the submission team rebuilds the dataset from scratch. Every week of that effort is a week between study completion and IND or NDA filing. A data capture system designed around submission requirements from the start produces submission-ready output as a side effect of normal operations.
- 03
Your lab notebooks are physical binders that cannot be searched, shared between sites, or countersigned electronically for IP protection
When research is recorded on paper, a scientist at a second site cannot access the notebook, a colleague cannot countersign it without being in the same room, and a patent attorney cannot search it without physically reviewing every page. If a priority date dispute arises, the documentation is slow to produce and hard to verify. An electronic lab notebook with structured entries, electronic countersignature, and full-text search makes the research record immediately accessible and legally defensible.
- 04
Your LIMS handles sample tracking but has no instrument integration, so technicians re-enter results manually from instrument printouts
When instrument results are printed, checked by a technician, and manually entered into the LIMS, the manual transcription step introduces the most common source of data integrity failure in laboratory operations: transcription error. An instrument that produces 200 results per day creates 200 opportunities for a digit to be entered incorrectly. Direct instrument integration -- via API, ASTM interface, or file-based import -- eliminates the transcription step and the error it introduces, and creates a direct link between the raw instrument output and the LIMS result record.
What we build
Laboratory Information Management System (LIMS)
Sample registration and tracking through every stage of the laboratory workflow -- receipt, storage, testing, review, and disposal -- with sample status and location visible at all times. Test order management linking samples to the analytical methods and instrument assignments for each test. Result capture from instrument integrations (direct API or file-based import) and manual entry with the units, ranges, and pass/fail criteria for each test type. Result review and approval workflow with electronic signature. Certificate of analysis generation from approved results. The LIMS that replaces paper worksheets and gives your laboratory the data traceability a regulatory inspection requires.
Electronic lab notebook (ELN)
Structured experiment records replacing paper lab notebooks with searchable, version-controlled, electronically signed entries. Experiment templates capturing the protocol, materials, equipment, and observations in a consistent format. Data attachment supporting instrument exports, images, chromatograms, and spectra linked to the experiment record. Collaboration features for multi-researcher experiments with contribution tracking. IP protection through timestamped, countersigned records that establish priority and demonstrate inventive step. The ELN that makes research data findable, shareable, and defensible.
Clinical trial data management
Protocol management capturing the study design, endpoints, visit schedule, and inclusion/exclusion criteria. Subject enrolment and randomisation with eligibility verification against the protocol criteria. Electronic data capture (EDC) for case report form completion with field-level validation and query management. Adverse event and SAE reporting with regulatory notification workflow. Site management covering investigator site files, monitoring visit records, and deviation tracking. Clinical data export in CDISC SDTM and ADaM format for regulatory submission. The clinical data platform that keeps your study in protocol and your submission data structured for FDA review.
Bioinformatics pipeline platform
Next-generation sequencing data processing pipelines covering alignment, variant calling, annotation, and quality control with configurable workflow steps and parameter management. Genomics data storage with sample linkage, metadata management, and version control for reference data. Pipeline execution management showing run status, resource usage, and output file tracking. Results visualisation for variant data, expression profiles, and pathway analysis. Data sharing with controlled access for collaboration between internal and external research teams. The bioinformatics infrastructure that turns raw sequencing output into analysed, reproducible, shareable results.
FDA 21 CFR Part 11 compliance
Audit trail capturing every record creation, modification, and deletion with the user identity, timestamp, and previous value -- the complete change history that 21 CFR Part 11 and EU Annex 11 require. Electronic signature workflow with identity verification, meaning capture, and the binding of the signature to the record. Access control with role-based permissions, password policy enforcement, and inactivity timeout. System validation documentation -- User Requirements Specification, Functional Specification, IQ/OQ/PQ protocols, and Validation Summary Report -- produced alongside the software. Change control procedure for post-validation modifications maintaining the validated state.
Regulatory data and submission tools
Data compilation tools aggregating study data, analytical results, and supporting documentation into the structured format required for IND, NDA, BLA, or MAA submissions. eCTD document management with module structure, document versioning, and submission package assembly. Regulatory correspondence tracking with response timelines and commitment management. Post-approval change control documentation workflow. The regulatory data management that reduces the time between study completion and submission ready by making the submission data a structured output of normal operations rather than a manual compilation exercise.
How we work with biotech clients
- 01
Discovery
We map your laboratory workflows, regulatory obligations (21 CFR Part 11, EU Annex 11, GxP guidelines), and the instrument types requiring integration before any design begins. For clinical trial projects, we document the study protocol structure, data capture requirements, and CDISC submission format requirements at this stage.
- 02
Architecture
We design the data model with regulatory compliance as a first-class constraint: audit trail schema, electronic signature binding, role-based access controls, and the validation documentation plan. Instrument integration approaches are confirmed based on available APIs and interface protocols for your specific equipment.
- 03
Build
Two-week sprints with working software at each checkpoint. Core sample tracking or data capture functionality ships first. Instrument integrations, review workflows, electronic signatures, and reporting follow in subsequent sprints, with IQ/OQ protocol documentation written in parallel.
- 04
Launch and support
Performance Qualification is executed with your validation team against your specific processes. The Validation Summary Report and supporting documentation are delivered alongside the live system. Post-launch support covers regulatory updates, new instrument integrations, and change control documentation for post-validation modifications.
Frequently asked questions
Validation is scoped as part of the development project rather than treated as a separate post-development activity. We produce the User Requirements Specification and Functional Specification during the discovery phase so requirements are documented before development starts. Installation Qualification and Operational Qualification protocols are written in parallel with development and executed during the testing phase. Performance Qualification is executed with the client's validation team against their specific processes. The Validation Summary Report and supporting documentation are delivered alongside the software. The validation approach is discussed and agreed at project kickoff so the timeline and deliverables are clear.
Yes. Instrument integration is a core part of LIMS implementation. We support direct API integration where instruments provide it, bi-directional instrument interfaces via ASTM or HL7 protocols, file-based import from instrument software exports (CSV, XML, proprietary formats), and middleware integration platforms. The integration approach for each instrument is assessed during discovery -- not all instruments provide equivalent integration capability, and we confirm what is achievable for your specific equipment before development starts.
Genomics data is large by nature and the storage and compute architecture needs to be designed for it from the start. We build bioinformatics platforms on cloud infrastructure (AWS, Azure, or GCP) with scalable storage and on-demand compute for pipeline execution, so you pay for the capacity you use rather than provisioning for peak. Data archiving workflows manage the lifecycle of raw sequencing files, intermediate files, and final outputs. We assess your anticipated data volume and pipeline complexity during discovery and propose the right infrastructure architecture before development starts.
A LIMS covering sample tracking, test management, result capture, and audit trail typically runs $55,000 to $110,000. A more complete platform with ELN, clinical data management, or bioinformatics pipeline integration typically runs $110,000 to $220,000. Validation documentation is included in the project scope and cost. Fixed cost agreed before development starts.
Yes. Data migration of historical laboratory records -- paper worksheets, Excel exports, legacy LIMS exports -- is a standard part of biotech software projects. We structure the migration around sample identifiers, analytical methods, and result records so the new system starts with an accurate historical baseline. For paper records, we scope a structured data capture process as part of migration. The migration approach is confirmed during discovery so the timeline and quality controls are clear before development starts.
Biotech software by product
LIMS Development
Sample tracking, instrument integration, result management, and CoA generation
Electronic Lab Notebook (ELN)
Structured experiment records, IP protection, and 21 CFR Part 11 compliance
Clinical Trial Data Management Software
EDC, subject management, AE reporting, and CDISC submission data
Bioinformatics Pipeline Platform
NGS processing, genomics data management, and results visualisation
What clients say
What our life sciences clients say
Three-year average engagement. Founders and operators describing the work in their own words. No marketing varnish.
D
Dr. Smith
Primary Care Physician
PDC has been a great addition to our clinic. It is easy to navigate, and as a remote patient monitoring app, it helps us stay connected with senior patients who cannot visit regularly.
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Related services
- AI Document Intelligence -- Extract structured data from clinical trial reports, lab results, regulatory submissions, and audit trails
- AI Agent Development -- Autonomous agents for literature review, protocol deviation monitoring, and regulatory document generation
- Business Process Automation -- Automate sample tracking workflows, equipment calibration scheduling, and regulatory reporting
- Custom Software Development -- Custom LIMS, ELN, and clinical data management platforms built to your GMP/21 CFR Part 11 requirements