Software development and AI pod teams for life sciences

Ryz staffs senior Latin American engineers and dedicated AI pod teams for pharma, biotech, medtech and CRO teams. Our teams build clinical and lab data platforms, Veeva and LIMS integrations, quality and regulatory systems and commercial tools, and our AI pods build systems for document-heavy work like promotional review and safety case intake in a way your validation team can document. They work on US business hours, alongside your R&D IT, quality and commercial technology teams.

What we build for life sciences teams

Life sciences software is split between GxP systems, where every change is validated and every record has an audit trail, and non-GxP systems that move at normal product speed. Our engineers work on both and know which is which:

• Clinical data platforms. Pipelines from EDC, eCOA, labs and wearables into SDTM-ready datasets, with lineage from each derived value back to source.
• Clinical operations tooling. Study startup trackers, site and patient recruitment portals, CTMS integrations and trial master file automation.
• Lab informatics. LIMS and ELN integrations with LabWare, STARLIMS or Benchling, instrument data capture, and sample tracking.
• Quality and regulatory systems. Deviations, CAPA, change control and document management on Veeva Vault QualityDocs or MasterControl, and submission assembly for eCTD.
• Manufacturing data. MES and historian integrations, batch record review support and serialization data for DSCSA.
• Commercial and medical platforms. CRM integrations with Veeva CRM or Salesforce, HCP portals, medical information request handling and field force analytics.
• Medtech and connected device software. Companion apps, device cloud backends and data pipelines for connected devices, built around your design control process.

Where AI pods help in life sciences

The AI systems that get to production in life sciences tend to speed up reviewers and specialists rather than replace them. An AI pod builds them in your cloud:

• Promotional material review (MLR). Pre-checking claims in promotional pieces against approved labeling and references before medical, legal and regulatory review. The engineering challenge is claim-to-reference matching and showing reviewers each match. It follows the same pattern as the marketing compliance review one of our pods built for a global capital management firm, which covers more than 8,000 documents. See our case studies.
• Pharmacovigilance case intake. Extracting patients, products, events and reporters from emails, call notes and literature into ICSR fields, with a safety specialist confirming seriousness and causality.
• Regulatory and clinical document drafting. First drafts of clinical study report sections, protocol amendments and responses to health authority questions, grounded in source documents with citations. See RAG development.
• Medical information agents. Answering HCP questions from approved standard response documents, with escalation for anything off-label or unapproved.
• Literature and data search. Retrieval across internal reports, publications and study data for scientists, with access controls that respect study blinding.

Regulations and constraints our engineers work within

Our engineers have experience building within these requirements, alongside your quality assurance, regulatory and validation teams. Ryz does not validate or certify systems; your quality unit owns that.

• FDA 21 CFR Part 11. Electronic records and signatures: audit trails, signature manifestation, access controls and record integrity for systems in GxP use.
• GxP and data integrity. GCP, GMP and GLP expectations, and ALCOA+ principles for records that support regulated decisions.
• Computer system validation and CSA. Risk-based validation following GAMP 5 and FDA's Computer Software Assurance guidance, which determine how much testing evidence each change needs.
• ICH E6(R3) Good Clinical Practice. The updated GCP guideline, with its risk-based approach to trial conduct and computerized systems.
• EU GMP Annex 11. Computerised systems requirements for products made or sold in the EU.
• Human subjects and privacy. The Common Rule, HIPAA where covered data is involved, and GDPR for EU trial participants.
• DSCSA. Product tracing and serialization requirements for prescription drugs in the US supply chain.
• Promotion rules. FDA rules on prescription drug advertising and promotional labeling, which define what the MLR process checks.

Integrations and data

• Veeva Vault (Clinical, Quality, RIM, PromoMats) and Veeva CRM APIs.
• EDC systems such as Medidata Rave and Oracle Clinical One, and CTMS platforms.
• CDISC standards: CDASH, SDTM, ADaM and Define-XML, plus eCTD for submissions.
• Safety databases such as Oracle Argus and ArisGlobal LifeSphere, and E2B(R3) case exchange.
• LIMS, ELN, MES and historian systems, and data platforms on Snowflake, Databricks or AWS.

The practical difference in GxP work is that the documentation is part of the deliverable. Our engineers write requirements that trace to tests, keep configuration in version control with change records, and produce test evidence in the format your validation plan specifies. On non-GxP systems such as commercial analytics, the same teams move at ordinary product speed, which is why each system's classification should be settled before the first sprint.

How teams engage Ryz

Staff augmentation fits when your R&D IT or digital team needs more senior engineers: a data engineer on the clinical data platform, a Veeva integration developer, a QA engineer who writes test evidence your validation team accepts. They work on your team, under your SOPs. See our QA and testing work.

An AI pod fits when you want MLR pre-review, safety intake or document drafting built and in production. A pod is often around seven senior engineers including a tech lead, an ML engineer and backend engineers. A dedicated development team fits a scoped build like a study startup portal. For individual healthcare roles, see healthcare software developers.

Mid-level engineers run $7,000 to $10,000 per month, senior engineers $10,000 to $15,000 and leads $15,000 and up. Five senior engineers for six months at $12,000 is $360,000. You get a plan, a price and the names of the people before you start.

When Ryz isn't the right fit

• You need a validation services firm to own your CSV or CSA deliverables, or a CRO to run trials. Ryz teams build software and work within your quality system.
• You want a licensed clinical, safety or quality platform. Ryz does not sell software.
• You need engineers in European or Asian time zones for global study operations, or a management consultancy for R&D strategy.

Related

• Healthcare software development
• AI agent development
• Partners to take an AI pilot to production
• Logistics software development
• Hire data engineers

FAQ

Can your engineers work on GxP systems?

Yes. Our engineers have worked under change control, written and executed test scripts, and produced documentation for validated systems. They follow your SOPs and quality system. Your quality unit approves and owns validation.

How do your engineers handle patient and trial data?

They work in your environment and under your controls: your cloud, identity provider, managed devices and data access approvals. Your privacy and clinical data teams decide what they can see, and blinded data stays blinded. Ryz does not claim HIPAA or GxP certification.

Can AI be used in a GxP process?

It can, with care. The pod defines intended use, builds evaluation sets with your subject matter experts, versions models and prompts, logs inputs and outputs, and keeps a qualified person approving each result. Your quality team decides how the system is validated.

What does a life sciences engineering team cost?

Typical rates are $7,000 to $15,000 per engineer per month by seniority, with leads at $15,000 and up. Project cost is team size times duration times rate, quoted per team.

Do your engineers know CDISC and Veeva?

Our engineers have built pipelines to SDTM and ADaM datasets and integrated with Veeva Vault and Veeva CRM APIs, along with EDC and safety systems.

Questions we didn't answer? Email info@ryzlabs.com.