Clinical Trial Configuration Portal for PharmaTech Platform
- React
- S3
- Node.js
- Kubernetes
- DynamoDB
- AWS
SERVICES
EXPERTISES
Project Context
Solution
Outcome
About Client
Our client is a US-based tech company operating a B2B platform that enables pharmaceutical companies to manage and run clinical trials at scale.
Their platform serves clinical trial participants and Clinical Trial Managers (CTMs), incorporating AI-powered OCR technology to assess participant well-being through video submissions. While their platform excelled in backend capabilities, AI functionality, and participant-facing UX, the trial configuration process remained their operational Achilles' heel.
Business challenge
The bottleneck was costing time, money, and client satisfaction.
For pharmaceutical sponsors and CTMs, launching a new clinical trial should be straightforward. Instead, our client's customers faced a frustrating reality:
- Weeks-long delays just to schedule configuration meetings between the client's IT staff and CTMs
- Overworked IT teams drowning in a backlog of trials waiting to be configured, forcing the company to pay costly overtime
- Zero visibility for CTMs into their trial's configuration progress, leading to anxiety and repeated follow-ups
- Error-prone manual processes that required multiple review cycles to catch missing or incorrect data entries
- Communication overhead every time a pre-trial adjustment was needed
The outdated configuration tool lacked basic UX principles and offered no summaries or progress tracking. CTMs – highly skilled specialists who should be focusing on trial design and participant safety – were instead stuck chasing IT teams for status updates and corrections.
The stakes? Delayed trial launches mean delayed drug development timelines, which ultimately delays treatments reaching patients. For a B2B platform competing in the pharmaceutical tech space, this operational friction was a competitive liability.
Approach
Binariks dedicated an intensive discovery phase, assembling a specialized team that included a Clinical Trials Subject Matter Expert – allowing us to speak the language of pharmaceutical operations, not just software.
During discovery, we:
- Mapped the existing configuration workflow, identifying where manual handoffs created delays and errors
- Analyzed the client's backend data structures to ensure seamless integration without platform rewrites
- Prepared comprehensive data mapping and transformation rules to accelerate testing and validation
- Designed a UX strategy centered on guided workflows with real-time validation
Team Structure
We matched team composition to each phase:
- Discovery: Full-time Senior BA, SME, and UI/UX Designer, with part-time Tech Lead, Solution Architect, and QA Engineer developing the test plan
- MVP delivery: Scaled to 11 specialists (3 fullstack developers, 2 QA engineers, and part-time DevOps) working in parallel to meet the Q2 deadline
- Maintenance: Transitioned to on-demand support
The Fullstack Tech Lead with integration expertise bridged our portal with the client's AWS-based platform, ensuring architectural alignment.
Execution Strategy
Rather than replacing the old tool, we built a self-service portal that empowered CTMs while maintaining IT oversight through a "master role." We captured test results in the client's Quality Management System format – critical for regulatory compliance.
Implementation
Binariks delivered a standalone, self-service web portal that transformed clinical trial configuration from an IT-dependent bottleneck into an intuitive, automated workflow for clinical trial managers (CTMs).
Architecture Overview
The solution was designed to align with the client’s AWS ecosystem and existing DevOps practices, ensuring seamless integration and long-term maintainability:- Frontend: React application hosted via AWS CloudFront and S3 for secure, low-latency global access.
- Backend: Node.js services running in Kubernetes pods within the client’s AWS EKS cluster.
- Database: AWS DynamoDB for scalable, high-performance data storage.
- Authentication: Integration with the client’s OAuth-based service for consistent access control.
- Monitoring: AWS CloudWatch for real-time log tracking and performance insights.
A serverless architecture (AWS Lambda) was evaluated but replaced with a Kubernetes-based model to match the client’s infrastructure, CI/CD pipelines, and in-house expertise.
Architecture Decision
A serverless architecture (AWS Lambda) was evaluated but replaced with a Kubernetes-based model to match the client’s infrastructure. Forcing a Lambda-based approach would have created operational friction and slowed their ability to maintain the solution independently. The chosen architecture aligned with their existing CI/CD pipelines, deployment practices, and in-house team expertise.Core Features and Capabilities
- Trial metadata: Study name, protocol number, sponsor details, regulatory classifications
- Treatment plans: Complex dosing regimens including AM/PM schedules, titration rules, and blinding configurations
- Visit schedules: Calendar-based period management with support for negative durations (e.g., screening periods before Day 1)
Extensive data mapping and validation during discovery ensured flawless backend integration and regulatory compliance.
Key Platform Capabilities
- Centralized trial management dashboard: CTMs, sponsors, and stakeholders access a consolidated view of all trials with real-time status indicators ("in validation," "in production"). No more emails asking "where are we with Trial XYZ?"
- Configurable trial setup wizard: A guided, step-by-step interface walks users through trial creation with inline validation and progress indicators. The system catches configuration errors before submission, not after multiple review cycles.
- Advanced configuration forms: Purpose-built interfaces for trial metadata, schedules, treatment plans, site management, and a custom questionnaire builder.
- Visualized trial schedule: Calendar-style overview displaying the trial timeline, periods, visits, and milestones. What previously required spreadsheets and manual documentation now renders automatically.
- Live preview and final summary: Before submission, users verify the entire configuration through summarized sections and printable views.
- Change auditability: Detailed logs capture every configuration update, showing which user made what changes and when. Essential for regulatory compliance and troubleshooting.
- Integration hooks: Real-time provisioning and automatic validation checks connect to the client's platform backend, ensuring data consistency without manual intervention.
- IT team enhancement: A "master role" provides the IT team access to all trials with significantly improved UX. They can now oversee and assist with configuration efficiently, with all IT team changes highlighted in summaries and audit logs.
Data Integrity Foundation
Extensive data analysis and mapping ensured absolute alignment with the client's backend systems.
It was foundational work completed during discovery, including transformation and validation rules development that prevented the "we'll figure it out later" trap that derails many integration projects.
Value Delivered
The configuration bottleneck is now a competitive advantage.
The numbers tell part of the story:
- ~80% reduction in average trial setup time
- Zero back-and-forth communications required for the most common workflow (double-blinded trials)
- +3 ESAT score improvement for the client's IT team within three months—the same team that was previously overworked and burning out
But the real impact goes deeper:
For CTMs and Pharmaceutical Sponsors:
- Independence to configure and launch trials without waiting for IT availability
- Complete visibility into configuration status at every step
- Confidence that comes from real-time validation and visual schedule verification
- Faster onboarding thanks to intuitive UX that doesn't require training manuals
For the Client's Business:
- Elimination of overtime costs that were bleeding the budget
- IT team capacity freed up to focus on platform development instead of low-value configuration tasks
- A self-service model that scales – no longer constrained by IT team size
- Trial launches measured in days or hours instead of weeks
Compliance and Audit-Ready Governance Built In:
The portal maintains full compliance with FDA and the pharmaceutical industry regulations, including 21 CFR Part 11 (electronic records and signatures) and HIPAA (Health Insurance Portability and Accountability Act).
The architecture implements organization-level data isolation to prevent cross-contamination between pharmaceutical sponsors and provides comprehensive audit trails that capture every configuration change with user attribution and timestamps.
This regulatory-first design approach ensures pharmaceutical sponsors can confidently use the platform for clinical trials, knowing all compliance requirements are built into the foundation – not bolted on as an afterthought – and that audit-ready documentation and traceability are provided from day one.
In pharmaceutical technology, speed means getting treatments to patients faster.
By eliminating this operational bottleneck, the solution contributes to accelerating drug development timelines across multiple trials and pharmaceutical companies.
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