Health Sciences
Behavior-Defined Engineering for Regulated Health Sciences
BiTE Interactive engineers regulated software systems where behavior is explicitly defined, continuously verified, and observable in operation—so change remains controlled.
Joel KORDYAK
“We needed a responsive, web-based sales tool on a very tight deadline. BiTE guided us through every step of our project and were completely committed to our success.”
Lee Ames
Senior Director Product Marketing
“Our app’s spending system was more complicated than anything a dating app had done before. BiTE was able to make sense of each possible scenario and use BDD to test for every possible outcome. The result was an app that worked beautifully and didn’t drive us crazy in the process.”
Robin Leigh
Director of Communications“We asked BiTE to pick up another vendor’s project. They audited the code and made corrections and improvements fast. They integrated seamlessly with our team as well as worked directly with our most important clients.”
Mike Feinberg
Vice President of Technology
Behavior Is the Contract
BiTE engineers regulated systems so behavior itself is the contract. Critical workflows are defined precisely, exercised continuously, and traceable at runtime. This approach applies across pharma, biotech, medtech, digital health platforms, research infrastructure, and adjacent regulated products, without constraining delivery to a single domain or protocol.
Living Documentation
We use Behavior-Driven Development (BDD) to define system behavior in concrete, executable terms. Business-critical workflows are specified in Gherkin and treated as living documentation, not static requirements.
Operational outcomes
- Explicit, reviewable definitions of regulated behavior
- Continuous verification against implementation
- Durable specifications that remain valid over time
Event-Driven Audit Logs
We design systems using event-driven architecture so meaningful actions emit explicit, timestamped events. Each event is captured in an immutable audit log, creating a transparent, real-time record of system behavior across workflows, integrations, and data changes.
Operational outcomes
- Immediate visibility into what happened and when
- Defensible reconstruction of system state across releases
- Clear linkage between user actions, system decisions, and data changes
Validation Pipelines
BiTE applies Computer Software Assurance (CSA) explicitly as a post–code-freeze validation step. Once development stabilizes, we execute a dedicated validation pipeline that confirms the system functions as specified.
Operational outcomes
- Validation grounded in real system behavior
- Documented evidence produced without parallel manual processes
- Repeatable confirmation as systems evolve
CSA Validation
A dedicated validation pipeline executes the approved behavior set against the deployed system and collects objective evidence that the system functions as specified. This evidence is retained as part of the CSA record and supports regulatory review without parallel documentation workflows.
Operational outcomes
- Validation grounded in execution
- Objective evidence tied directly to approved behavior
- Repeatable confirmation as systems evolve
Living Documentation
BiTE engineers clinical AI so the intended use, decision authority, and review basis remain explicit at runtime. The result is AI that supports clinician judgment while producing audit-ready evidence and validation records prior to release.
Operational outcomes
- FD&C Act §520(o)(1)(E) and 2026 FDA CSA compliance
- Defined intended user (HCP), decision boundaries, and human-in-the-loop enforcement at critical points
- Input disclosure, data quality controls, and plain-language algorithm descriptions appropriate to the intended HCP
- Clear performance boundaries plus validation summaries that remain traceable through change
Compliance by Design
Explicit behaviors, traceable from requirement to release
Clinical Trial Systems Delivered at Scale
BiTE owned end-to-end delivery across 26 active clinical trials over 4 years, including project management, full-stack development, and QA/validation and support. We translated approved protocols into operational software, stood up production trial environments, and supported large-scale global studies through live execution.
Protocol amendments and live updates were managed under controlled release processes while trials were running, preserving traceability and operational stability as requirements changed.
The result: proven delivery capacity, regulatory compliance, and PHI security for global trial systems operated under continuous change.
CRA App
From strategy, through iOS and Android development with Salesforce integration – learn how BiTE saved ICON $8.5M /year.
ICON's Trial Platform
Learn how BiTE streamlined ICON’s development process, trained staff in Agile and Behavior Driven Development, directly managed the offshore team, and handled requirements writing and system architecture design.
Phase 3 Global COVID-19 Study Rescue
Faced with tight timelines, a complex protocol with frequent protocol updates, and the need to maintain regulatory compliance across different countries in the middle of a global pandemic, ICON asked BiTE to rescue its COVID trail projects.
Care Innovations
Safe Health
Experience Matters
Frequently Asked Questions
BiTE Interactive is a senior-only, onshore engineering partner. BiTE engineers FDA, HIPAA, and GDPR regulated health-science software where data integrity, traceability, and auditability must hold through change. We turn critical behavior into executable contracts and wire them into release gates.
Clinical data platforms, research platforms, medical device software, and adjacent regulated products where controlled change and defensible system behavior are required.
Behavior-Driven Development (BDD) defines executable requirements and keeps approved behavior explicit as the system evolves. It provides objective traceability of requirements, change control, and behavioral intent.
No. BDD does not replace CSA. BDD establishes and enforces correct behavior during development. CSA is a distinct, FDA-required validation step performed after code freeze that confirms the system functions as specified and produces formal validation evidence.
BDD provides executable specifications and objective traceability throughout delivery. CSA validation confirms behavior after code freeze and collects objective evidence aligned with FDA regulations and guidance.
We enforce explicit write ownership, traceable state transitions, and durable audit evidence so records remain consistent, reviewable, and defensible as systems scale and change.
BiTE integrates into existing engineering organizations, adapts to established SDLC constraints, and navigates organizational dynamics so delivery controls and evidence pathways become operational.
Systems are designed using event-driven architecture so meaningful actions emit explicit events. These events are captured in an immutable audit log, providing real-time, reviewable traceability across workflows, integrations, and data changes.
Yes. Engagements begin from the system’s current operating state. Additional controls—such as executable specifications, validation pipelines, and traceability—are introduced incrementally where they materially improve correctness, evidence generation, and controlled change.
BiTE is not a fit for advisory-only engagements where implementation, enforcement, and evidence-generation remain out of scope.