Drug safety software development with a team that already knows the domain
We build pharmacovigilance and life-sciences systems for a living — a safety database, a LIMS, regulatory tooling, an integration nobody else will own. You get engineers who understand audit trails, Part 11 and traceability before the first sprint, and the documentation set that makes the result defensible.
- Model
- Dedicated team, fixed scope, or staff extension
- Domain
- Safety databases, LIMS, regulatory tooling
- Built to
- GxP, GAMP 5, 21 CFR Part 11 principles
- Deliverables
- Working software plus IQ/OQ/PQ and RTM
What drug safety software development means here
Drug safety software development is the design and build of systems that hold regulated safety data: ICSR case-management databases, laboratory information management systems, regulatory submission tooling, and the integrations between them. It differs from ordinary application development in what the software has to prove rather than what it has to do — every change traceable to a requirement, every record auditable with before and after values, electronic signatures that hold up, and a documentation set an inspector can follow. PVgenix builds these systems as a software development provider: we deliver the application against your requirements and specifications, and your qualified personnel own the pharmacovigilance and regulatory decisions the software records.
- A team that has already built a GxP-aligned safety platform, not one learning the domain on your budget
- Requirements, design, build and test documented as you go, because retro-fitting traceability costs more than producing it
- Audit logging, RBAC and electronic-signature patterns as defaults, not as a hardening phase at the end
- IQ / OQ / PQ protocols, a Requirements Traceability Matrix and SOP templates delivered with the software
- Legacy migration, load and performance testing, and ongoing maintenance and re-qualification support after go-live
When commissioning a build beats buying a product
Most companies should buy the platform — it is faster and cheaper. These are the three situations where it genuinely is not the answer.
Your process does not fit a product
A workflow, a data model or a regulatory position that no off-the-shelf system supports, and configuring around it would leave you fighting the tool for years.
You need a system that is not a safety database
A LIMS, a regulatory document system, a reconciliation tool, a patient-support platform. Same compliance constraints, same traceability expectations, different application.
You have the roadmap but not the engineers
Hiring in this domain is slow, and generalist contractors spend the first quarter learning what an audit trail has to capture. A team that already knows starts producing sooner.
What the team delivers
Scope is agreed per engagement. Where an existing PVgenix component or the platform base covers part of the requirement, we will say so rather than bill you to rebuild it.
Systems we take on
The common thread is regulated data with an audit obligation, not any one application category.
- ICSR case-management and safety databases
- Laboratory information management systems (LIMS)
- Regulatory submission, tracking and document systems
- Signal, surveillance and analytics tooling
- Reconciliation between clinical and safety data sources
- Integrations and system-to-system feeds nobody currently owns
Built to the compliance baseline
The patterns that are expensive to add late and cheap to build in from the first sprint.
- 21 CFR Part 11 electronic records and electronic signatures
- GAMP 5 lifecycle and GxP operational alignment
- Full audit logging: who, what, when, before and after values
- Role-based access control with least-privilege and segregation-of-duties design
- Encryption in transit and at rest, and secure secrets management
- Defined backup procedures and recovery objectives
The documentation set
Delivered alongside the software rather than assembled afterwards, which is the difference between a system you can qualify and one you have to reverse-engineer first.
- Validation Master Plan and User Requirement Specification
- Functional Specification and Design Specification
- IQ / OQ / PQ protocols
- Requirements Traceability Matrix
- SOP templates and IT / infrastructure documentation
- Load-testing reports and performance qualification evidence
Engineering services around the build
The work that decides whether a system actually goes live, as opposed to passing a demo.
- IQ execution support
- Load and performance testing
- IT setup, environment and configuration services
- Migration from a legacy safety database, including E2B transfer and field-level mapping and reconciliation
- Ongoing maintenance and re-qualification support on releases
How a team is composed
A realistic engagement, and who does what in it. The mix shifts across the engagement — heavier on analysis and architecture early, heavier on test and documentation before go-live.
| Role | What they do | When they are heaviest |
|---|---|---|
| Engagement lead | Owns scope, the requirement backlog and the delivery plan; single point of contact and the person who tells you when something is going wrong. | Throughout, part-time. |
| Solution architect | Data model, system boundaries, integration design, and the audit and access-control patterns everything else is built on. | Front-loaded, then on call for design decisions. |
| Backend engineers | Application and data layer, business rules, integrations, audit logging and the API surface. | The bulk of the middle of the engagement. |
| Frontend engineers | The interface your users actually work in, including accessibility and the review and sign-off flows. | Starts once the data model settles. |
| QA / test engineers | Test design traced to requirements, execution evidence, regression suites, and the test artefacts your qualification will reference. | Ramps up steadily; peaks before go-live. |
| Documentation / CSV support | URS, FS, DS, IQ/OQ/PQ protocols, RTM and SOP templates, produced alongside the build rather than after it. | Continuous, peaking at handover. |
| DevOps / IT | Environments, deployment, backups, monitoring, and the infrastructure documentation that goes with them. | Setup phase and each environment promotion. |
| Your side of the table | Requirement ownership, PV and regulatory correctness, acceptance, SOP content, and qualification execution. | Requirement definition and acceptance, then qualification. |
The last row is not filler. A build fails most often because nobody on the client side was accountable for deciding what the software should do — and we cannot make that decision for you, because PVgenix is a software development provider and not a pharmacovigilance or regulatory advisory service.
How an engagement runs
Documentation is produced as the work happens. That is the single biggest difference between a system you can qualify and one where traceability has to be reconstructed from commit history.
- Step 1
Scoping and honest triage
What you need, and whether a build is really the answer. If the platform or a licensable component covers most of it, we will tell you — a smaller engagement that succeeds is worth more to us than a large one that stalls.
- Step 2
Requirements and architecture
URS agreed and signed, data model and integration boundaries designed, audit and access-control patterns fixed, and the traceability structure set up before the first feature is written.
- Step 3
Build in increments
Working software at a regular cadence, each increment traced to requirements and tested with evidence retained. Where an agreed scope sits on the existing platform base, delivery typically completes within roughly a month, depending on requirements.
- Step 4
Handover, qualification support, maintenance
Documentation set delivered, IQ execution supported, load testing evidence provided. Your QA or CSV team runs qualification. After go-live, maintenance and re-qualification support continue under an agreed arrangement.
Three ways to engage a team
The choice is really about who owns scope. Fixed scope means we do; a dedicated team means you do, sprint by sprint.
Fixed-scope build
A requirement you can specify up front — a defined system, a migration, a specific integration.
- Agreed scope, milestones and acceptance criteria
- Documentation set for the delivered scope
- Test evidence traced to requirements
- A change process for anything outside the agreed scope
Quoted per milestone against an agreed scope, after the requirements phase.
Dedicated team
Most commonA roadmap rather than a specification, where priorities will move and you want to steer them.
- A named team, allocated to you and not time-sliced across clients
- You own the backlog and set sprint priorities
- Documentation produced continuously alongside the build
- Scale the team up or down at agreed notice
- Direct access to the engineers, not through an account manager
Quoted per month, per named team member, by role and seniority.
Team extension
You already have engineers and need specific domain or compliance capability alongside them.
- Named specialists joining your existing team and process
- Domain review of your data model and audit design
- CSV documentation and test-evidence support
- Knowledge transfer to your team as an explicit deliverable
Quoted per month, per named engineer, with a minimum engagement term.
We publish no rate card, and not out of coyness: a day rate on a web page is a number we would have to correct on the call, because the real figure depends on team size, role mix, seniority, engagement length and how much of the requirement the existing platform base already covers. Bring a rough scope and a timeline and you get a real quote, including the case for not building at all if that is what we find.
What we are not
We are not a pharmacovigilance consultancy. PVgenix provides software development. We do not perform PV operations, act as your QPPV, author your SOP content, interpret regulation on your behalf, or provide business-analysis or regulatory-advisory services. You define the requirements and own the correctness of PV content and regulatory rules; we build the system that implements them.
We do not deliver a system in a qualified state. We deliver working software, the environment, and the documentation set that supports qualification. Executing that qualification against your environment, requirements and SOPs is your QA or CSV team's work, and it takes time beyond any build timeline quoted here.
We are not equally deep in every domain. Our own product is a pharmacovigilance platform, so safety data, ICSR workflow, E2B exchange, coding and regulatory reporting are where the team has the most depth. Adjacent systems such as a LIMS or a regulatory document system share the compliance and traceability constraints we build to every day, and we will be explicit at scoping about where you are buying domain experience and where you are buying engineering that learns your domain with you.
We are not a body shop that will build whatever is asked. If a requirement is better served by the existing platform, by licensing a component, or by not building at all, that is what we will say at scoping. A stalled custom build costs you more than the sale is worth to us.
We do not supply third-party licensed content. MedDRA, the WHO Drug Dictionary and similar terminologies and data subscriptions are procured and licensed by you; we integrate them into what we build.
Answers before the call
The questions that come up in most scoping conversations. If yours is not here, ask it on the call.
Browse the full FAQYes. The common requirement is regulated data with an audit obligation, which covers laboratory information management systems, regulatory submission and document tooling, surveillance and analytics applications, reconciliation between clinical and safety sources, and integrations between existing systems. Our deepest domain depth is pharmacovigilance, because that is what our own product is, and we say so at scoping rather than implying equal experience everywhere.
By the model you choose rather than by a published rate. A fixed-scope build is quoted per milestone once requirements are agreed; a dedicated team is quoted per month per named team member by role and seniority; a team extension is quoted per named engineer with a minimum term. We do not publish day rates because the real figure turns on team size, role mix, seniority, engagement length and how much of the requirement the existing platform base already covers.
Where an agreed scope sits on the existing platform base, delivery typically completes within roughly a month, depending on your specific requirements. A system built from scratch is longer and the requirements phase is what determines it — which is why we scope and quote that phase separately rather than guessing a total on a first call. None of these figures include your qualification execution, SOP authoring or UAT.
Set in the agreement, and it depends on what is being built. Work produced specifically to your requirements is normally assigned to you. Where a build reuses existing PVgenix platform code or a licensable component, that part stays ours and you receive a licence to it — which is usually the cheaper outcome, because the alternative is paying to rebuild something that already exists. We settle this in writing before the build starts, not at handover.
PVgenix is validation-ready and audit-ready: it ships with a complete IQ/OQ/PQ documentation package to support client-led validation. 'Validated' is a state achieved only after qualification is executed in a specific client environment.
PVgenix develops and delivers the software, the environment setup, and the supporting documentation. The client and their qualified PV personnel own PV decisions, regulatory interpretation, validation execution, and compliance obligations.
Yes, and it is usually a distinct workstream rather than a step. Standard E2B transfer covers the structured case data; beyond that, migration tooling handles legacy extraction, field-level mapping and reconciliation for the fields E2B does not carry. Expect the mapping decisions and the reconciliation evidence — not the transfer itself — to take the time, because those are what your QA team will review.
Maintenance and re-qualification support continue under an agreed arrangement: fixes, releases, and the updated documentation and test evidence each release needs so your qualified state stays maintainable. Handover to your own engineers is a legitimate end state and can be an explicit deliverable — if that is the plan, say so at scoping so knowledge transfer is built into the engagement rather than improvised at the end.
Buy, in most cases — a configured product is faster and cheaper than a build, and the platform covers the standard ICSR workflow. Building is the right call when your process or data model genuinely does not fit a product, when the system you need is not a safety database at all, or when you have a roadmap and no engineers to execute it. We run that triage at scoping and will recommend against a build when the evidence points that way.
Bring us a rough scope
A page of requirements and a timeline is enough to start. You will get a team shape, an engagement model, a real figure — and a straight answer if we think you should buy rather than build.