Biotech software development company

We build fit‑for‑purpose biotech systems that accelerate discovery, de‑risk operations, and turn fragmented data into defensible insights across the lab-to-market continuum.

18+

years in software development

50+

biotech software developers

100%

in-house biotech team

We build fit‑for‑purpose biotech systems that accelerate discovery, de‑risk operations, and turn fragmented data into defensible insights across the lab-to-market continuum.

18+

years in software development

50+

biotech software developers

100%

in-house biotech team

  • Technology consulting

Defining an actionable roadmap that aligns scientific goals, compliance constraints, and budget. Deliverables typically include capability gaps, architecture options (cloud/on‑prem/hybrid), buy‑vs‑build recommendations, and a phased plan that unblocks near‑term wins while de‑risking scale.

  • Custom biotech software development

Designing, building, and validating bespoke applications around your workflows — from research ELNs and assay portals to production‑grade platforms. Expect modular architectures, auditable data trails, and UX your bench scientists will actually use, all delivered with Agile cadences and sprint demos to keep stakeholders aligned.

  • AI and machine learning solutions for biotech research

Operationalizing AI where it moves the needle: target discovery, virtual screening, ADME/Tox prediction, genomics, and imaging. We set up reproducible pipelines (feature stores, model registries, monitoring) so models are explainable and versioned and then embed results into your tools to augment human decision‑making.

  • Software and data integration with lab systems and medical devices

Connecting instruments and systems so data flows without manual re‑entry. We integrate LIMS, ELN, CTMS, MES/ERP, and EHR via APIs/SDKs; map HL7/FHIR where clinical exchange is needed; and enable IoT telemetry for device uptime and calibration tracking — reducing clickwork and error rates while raising traceability.

  • Data management and visualization

Implementing clean, governed data pipelines that ingest from instruments, LIMS/ELN, EDC, and public datasets; and modeling that data for analysis. We surface insights via role‑based dashboards (e.g., PI, lab manager, QA), cohort explorers, and drill‑downs so teams spot trends and make confident calls without exporting to spreadsheets.

  • Compliance and security support

Implementing access controls, encryption, audit trails, e‑signatures, and change control aligned to FDA 21 CFR Part 11, HIPAA/GDPR, CLIA, and ISO 13485. Validation packages (IQ/OQ/PQ), SOPs, and risk assessments are produced as part of delivery so audits become routine, not an afterthought.

  • Software modernization

Refactoring or re‑platforming legacy tools to cloud‑ready microservices and resilient UIs without losing institutional knowledge. We preserve data lineage, deprecate brittle components, and introduce improvements to extend the lifespan of critical systems and reduce total cost of ownership.

Solutions we help build

  • Laboratory Information Management Software (LIMS)
  • Bioanalysis software
  • Clinical Trial Management Systems (CTMS)
  • Electronic Laboratory Notebook (ELN)
  • Genomics and proteomics data platforms
  • AI‑powered drug development tools
  • DNA analysis software
  • Diagnostics and monitoring applications
  • Bioimaging software
  • Sample status management software

Laboratory Information Management Software (LIMS)

Building configurable LIMS that automate sample intake, chain‑of‑custody, plate maps, inventory, and QC. AI assists with anomaly detection (e.g., out‑of‑range results), instrument health, and workload forecasting; barcode/RFID and role‑based permissions ensure end‑to‑end traceability.

Laboratory Information Management Software (LIMS)

Bioanalysis software

Implementing pipelines for assay setup, curve fitting, normalization, and result review with guardrails and review/approve workflows. ML models flag outliers, predict assay drift, and recommend repeats, compressing turnaround time while lifting confidence in reported values.

Bioanalysis software

Clinical Trial Management Systems (CTMS)

Developing CTMS with site/startup tracking, visit schedules, issue management, and KPIs. Predictive analytics support enrollment planning and risk‑based monitoring; integrations with EDC, eTMF, and safety systems remove manual reconciliation and improve inspection readiness.

Clinical Trial Management Systems (CTMS)

Electronic Laboratory Notebook (ELN)

Delivering ELNs with structured templates, embedded data capture, reagent lookup, and compliant e‑signatures. NLP auto‑tags entries, suggests related experiments, and surfaces prior art so teams reuse knowledge instead of reinventing it.

Electronic Laboratory Notebook (ELN)

Genomics and proteomics data platforms

Building scalable pipelines for sequencing, alignment, variant calling, expression profiling, and proteomic quantification. AI/ML highlights significant variants, pathways, and biomarker candidates; cohort analytics and permissions keep PHI secure while enabling collaboration.

Genomics and proteomics data platforms

AI‑powered drug development tools

Building virtual screening, molecular modeling, de novo design, and QSAR/ADMET prediction workflows on HPC/GPU backends. Generative models propose candidates within synthetic constraints; docking/scoring and MD simulations help prioritize hits and reduce wet‑lab iteration.

AI‑powered drug development tools

DNA analysis software

Creating analysis suites for targeted panels and WES/WGS with automated QC, variant interpretation, and report generation. Knowledge‑base linking (ClinVar, gnomAD, COSMIC) and AI‑assisted classification speed up variant review and reduce VUS churn.

DNA analysis software

Diagnostics and monitoring applications

Engineering clinician‑ and patient‑facing apps for test ordering, device connectivity, and longitudinal monitoring. Models support earlier detection and triage, while audit trails and consent management satisfy regulatory expectations.

Diagnostics and monitoring applications

Bioimaging software

Delivering pipelines for microscopy/HCS, MRI/CT, and histopathology with robust segmentation, registration, and quantification. AI models accelerate cell counting, phenotype clustering, and anomaly detection; viewers are optimized for large tiled images and collaborative review.

Bioimaging software

Sample status management software

Implementing end‑to‑end specimen tracking across collection, storage conditions, thaw/refreeze cycles, and disposal. Forecasting models predict depletion and storage demand; alerts assist with stability windows and environmental deviations to protect sample integrity.

Sample status management software
Laboratory Information Management Software (LIMS)

Building configurable LIMS that automate sample intake, chain‑of‑custody, plate maps, inventory, and QC. AI assists with anomaly detection (e.g., out‑of‑range results), instrument health, and workload forecasting; barcode/RFID and role‑based permissions ensure end‑to‑end traceability.

Laboratory Information Management Software (LIMS)
Bioanalysis software

Implementing pipelines for assay setup, curve fitting, normalization, and result review with guardrails and review/approve workflows. ML models flag outliers, predict assay drift, and recommend repeats, compressing turnaround time while lifting confidence in reported values.

Bioanalysis software
Clinical Trial Management Systems (CTMS)

Developing CTMS with site/startup tracking, visit schedules, issue management, and KPIs. Predictive analytics support enrollment planning and risk‑based monitoring; integrations with EDC, eTMF, and safety systems remove manual reconciliation and improve inspection readiness.

Clinical Trial Management Systems (CTMS)
Electronic Laboratory Notebook (ELN)

Delivering ELNs with structured templates, embedded data capture, reagent lookup, and compliant e‑signatures. NLP auto‑tags entries, suggests related experiments, and surfaces prior art so teams reuse knowledge instead of reinventing it.

Electronic Laboratory Notebook (ELN)
Genomics and proteomics data platforms

Building scalable pipelines for sequencing, alignment, variant calling, expression profiling, and proteomic quantification. AI/ML highlights significant variants, pathways, and biomarker candidates; cohort analytics and permissions keep PHI secure while enabling collaboration.

Genomics and proteomics data platforms
AI‑powered drug development tools

Building virtual screening, molecular modeling, de novo design, and QSAR/ADMET prediction workflows on HPC/GPU backends. Generative models propose candidates within synthetic constraints; docking/scoring and MD simulations help prioritize hits and reduce wet‑lab iteration.

AI‑powered drug development tools
DNA analysis software

Creating analysis suites for targeted panels and WES/WGS with automated QC, variant interpretation, and report generation. Knowledge‑base linking (ClinVar, gnomAD, COSMIC) and AI‑assisted classification speed up variant review and reduce VUS churn.

DNA analysis software
Diagnostics and monitoring applications

Engineering clinician‑ and patient‑facing apps for test ordering, device connectivity, and longitudinal monitoring. Models support earlier detection and triage, while audit trails and consent management satisfy regulatory expectations.

Diagnostics and monitoring applications
Bioimaging software

Delivering pipelines for microscopy/HCS, MRI/CT, and histopathology with robust segmentation, registration, and quantification. AI models accelerate cell counting, phenotype clustering, and anomaly detection; viewers are optimized for large tiled images and collaborative review.

Bioimaging software
Sample status management software

Implementing end‑to‑end specimen tracking across collection, storage conditions, thaw/refreeze cycles, and disposal. Forecasting models predict depletion and storage demand; alerts assist with stability windows and environmental deviations to protect sample integrity.

Sample status management software
Get a solution roadmap

Tell us what you’re building, and we’ll return a concise architecture outline, timeline, and validation approach tailored to your existing ecosystem.

Benefits of our biotech solutions

01/04

IP rights ownership

Retain full ownership of source code and documentation, eliminate vendor lock‑in and evolve the solution on your own terms as your science and business change.

02/04

Scalability

Start small, scale fast — our architectures support bursty workloads, multi‑site rollouts, and growing data volumes without surprise rewrites or performance cliffs.

03/04

Security and compliance

Protect sensitive clinical and research data through layered security (encryption, least‑privilege access, audit logs, MDR), with validation and SOPs aligned to the standards your auditors expect.

04/04

AI‑enhanced data insights

Turn raw outputs into signal with embedded analytics and ML providing predictions, rankings, and quality cues so teams make faster decisions and focus on higher‑value work.

01

IP rights ownership

02

Scalability

03

Security and compliance

04

AI‑enhanced data insights

Whom we serve

Research labs
Icon
Pharmaceutical companies Icon
Clinical trial organizations Icon
Diagnostic centers Icon
Biotechnology startups Icon
Academic institutions Icon
Healthcare providers Icon
Biomanufacturing facilities Icon
Public health organizations Icon
Environmental biotech companies Icon

Our biotech software development process

Process drives predictability. At Innowise, we use a rigorous, compliant lifecycle so releases are reliable, auditable, and useful from day one.

Discovering & aligning

Clarifying goals, users, data sources, and constraints; then mapping current workflows and defining measurable success criteria. Outputs include a backlog, risks, and a validation plan.

Architecting & planning

Selecting cloud/on‑prem/hybrid targets, security controls, and data models; producing UI wireframes and API contracts. We plan sprints and milestones with clear acceptance criteria.

Building & integrating

Implementing features iteratively with CI/CD, code reviews, and automated tests. We integrate instruments and external systems (LIMS/ELN/EDC/MES/EHR) and provide sprint demos to keep teams aligned.

Validating & assuring quality

Running functional, performance, and usability tests; executing validation (IQ/OQ/PQ) and traceability matrices. Findings are documented for inspection readiness.

Deploying & migrating

Rolling out to production environments, migrating legacy data with reconciliation, and verifying integrations. We support pilots/UAT to de‑risk cutover.

Training & enabling users

Delivering role‑based training, SOPs, and admin playbooks so teams are productive from the start. Feedback is captured for the next iteration.

Monitoring & evolving

Operating with SLOs/SLAs, patching, and scaling resources. We roadmap enhancements and model monitoring (drift, bias) to keep solutions accurate and compliant.

Request a process walkthrough

We’ll show you artifacts (backlogs, validation packs, SOPs) from anonymized projects so you can see the rigor before we start.

Innowise’s partnerships

Novartis logo.Alliance Medical logo.ISO 27001 logo.HIPAA logo.GDPR logo.Telea logo. Megaomega logo. NAIP logo.
Novartis logo.Alliance Medical logo.ISO 27001 logo.HIPAA logo.GDPR logo.Telea logo. Megaomega logo. NAIP logo.
Novartis logo. Alliance Medical logo. ISO 27001 logo. HIPAA logo.
Novartis logo. Alliance Medical logo. ISO 27001 logo. HIPAA logo.
GDPR logo. Telea logo. Megaomega logo. NAIP logo.
GDPR logo. Telea logo. Megaomega logo. NAIP logo.
Google logo. Hays logo. PayPal logo. Siemens logo. Nike logo. Volkswagen logo. LVMH logo. Nestle logo. Novartis logo. Spotify logo.
Google logo. Hays logo. PayPal logo. Siemens logo. Nike logo. Volkswagen logo. LVMH logo. Nestle logo. Novartis logo. Spotify logo.
Aramco logo Mercedes logo. Costco Wholesale logo. Shell logo. Accenture logo. NVIDIA logo. SPAR logo. Mastercard logo. CVS Health logo. The Walt Disney logo.
Aramco logo Mercedes logo. Costco Wholesale logo. Shell logo. Accenture logo. NVIDIA logo. SPAR logo. Mastercard logo. CVS Health logo. The Walt Disney logo.
Google logo.Hays logo.PayPal logo.Siemens logo.Nike logo.Volkswagen logo.LVMH logo.
Google logo.Hays logo.PayPal logo.Siemens logo.Nike logo.Volkswagen logo.LVMH logo.
Nestle logo.Novartis logo.Spotify logo.Aramco logo.Mercedes logo.Costco Wholesale logo.
Nestle logo.Novartis logo.Spotify logo.Aramco logo.Mercedes logo.Costco Wholesale logo.
Shell logo.Accenture logo.NVIDIA logo. SPAR logo.Mastercard logo.CVS Health logo.The Walt Disney logo.
Shell logo.Accenture logo.NVIDIA logo. SPAR logo.Mastercard logo.CVS Health logo.The Walt Disney logo.

Why choose Innowise for biotech software

Domain‑deep, cross‑functional teams Icon

Drawing on 18+ years in software development and a dedicated biotech engineering group, we combine data experts, ML scientists, and regulated‑software developers with SMEs who understand assays, QC, and compliance. You gain a partner fluent in both biotech and code.

AI‑first where it matters Icon

We leverage AI to augment human expertise. Predictive models and automation are applied only where they produce measurable lift, while MLOps practices keep them reproducible, monitored, and compliant. This ensures innovation with control and clarity.

Compliance by design Icon

Quality and safety are built into every step of the software development lifecycle. We design for GxP, 21 CFR Part 11, HIPAA/GDPR, and ISO 13485 compliance from project inception, delivering validation artifacts and SOPs so you stay inspection‑ready without added overhead.

Smooth integration Icon

Our integrations are engineered for reliability and transparency. Using stable APIs/SDKs, HL7/FHIR standards, and resilient data models, we ensure your systems communicate seamlessly and preserve full lineage and provenance across platforms.

Flexible engagement Icon

Whether you need a dedicated team or fixed‑scope delivery, we adapt to your risk profile and internal capacity. Every engagement includes transparent reporting, full IP ownership, and a smooth knowledge transfer so you stay in control.

What our clients think

Marco Scarpa Technical Product Manager Beantech S.r.l
company's logo

It was a very intense and effective collaboration, all the developers were focused on the goals and prepared about all the technologies we cover.

  • Industry IT services
  • Team size 6 specialists
  • Duration 22+ months
  • Services IoT development
Nikolay Orlov CEO KEYtec AG
company's logo

What I found most impressive about Innowise was their ability to adapt to our specific needs while maintaining strict timelines. They combined a customer-centric approach with strong project management skills, ensuring that deliverables were of high quality and on time.

  • Industry Financial services
  • Team size 2 specialists
  • Duration 8 months
  • Services IT managed services
Gian Luca De Bonis CEO & CTO Enable Development OÜ
company's logo

We are impressed with their flexibility and willingness to find solutions for challenging situations. They actively assisted in every kind of situation. The team's willingness to deliver optimal results ensures the partnership's success.

  • Industry IT consulting
  • Team size 8 specialists
  • Duration 36 months
  • Services Staff augmentation

Frequently asked questions

How do you ensure data security in biotech software?

We implement layered security: encryption in transit/at rest, least‑privilege access, MFA, network segmentation, and continuous monitoring. We operate under ISO‑aligned processes and conduct regular penetration testing and audits.

How do you handle regulatory compliance?

Compliance is woven into requirements, design, and testing. We align with FDA, EMA, HIPAA/GDPR, CLIA, and 21 CFR Part 11, and provide validation packs (IQ/OQ/PQ), traceability matrices, and SOPs to pass inspections without last‑minute scrambles.

Can your software integrate with our existing lab equipment and platforms?

Yes. We integrate via vendor SDKs/APIs and established standards, connecting instruments, ELN/LIMS, CTMS/EDC, MES/ERP, and (where relevant) EHR systems to eliminate double entry and ensure clean lineage.

Do you work with startups as well as enterprises?

Absolutely. We tailor scopes and architectures to stage, from lean MVPs that hit fundraising milestones to multi‑site rollouts with strict validation.

What engagement models do you offer?

We support dedicated teams, staff augmentation, and fixed‑scope delivery. All models include IP ownership and knowledge transfer.

Feel free to book a call and get all the answers you need.

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    What happens next?

    1

    Once we’ve received and processed your request, we’ll get back to you to detail your project needs and sign an NDA to ensure confidentiality.

    2

    After examining your wants, needs, and expectations, our team will devise a project proposal with the scope of work, team size, time, and cost estimates.

    3

    We’ll arrange a meeting with you to discuss the offer and nail down the details.

    4

    Finally, we’ll sign a contract and start working on your project right away.

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