Peerbits Engineering Use Case · ClinTrial EDC
Clinical Research EDC Platform: Configurable eCRF & Study Management
Configure studies and eCRFs, manage participants and visits, capture structured clinical data, and maintain visibility and traceability from one unified research platform.
Use Case
Clinical research management & electronic data capture
Target Users
Investigators, coordinators, research nurses & data teams
Core Engine
Metadata-driven eCRFs + configurable workflows
Study Model
Multi-study & multi-site architecture
Governance
RBAC, schema versioning & immutable audit history
Demo
Working demonstration available
The Challenge
Overcoming Fragmented Research Data & Manual Spreadsheets
Clinical research operations frequently struggle with manual data entry, inconsistent form definitions across study sites, fragmented data silos, and a lack of point-of-capture validation.
Manual Entry & Inconsistent Forms
Paper case report forms and ad-hoc spreadsheets lead to transcription errors, missing mandatory fields, and varying form schemas between research sites.
Fragmented Study Data & Silos
Participant demographics, visit calendars, and lab observations stored in disparate tools without a single, synchronized source of truth.
Lack of Real-Time Auditability
Difficult to reconstruct the exact history of who entered or changed clinical observations, when edits occurred, and why values were updated.
Delayed Verification & Follow-Up
Missed participant visits, delayed adverse event escalation, and slow query resolution cycles between site coordinators and principal investigators.
Operational Context: These represent common operational bottlenecks encountered in clinical research environments, not universal claims about every research institution or trial protocol.
What Peerbits Engineered
Core Modules of the EDC Platform
Peerbits engineered a configurable Clinical Research Management & Electronic Data Capture (EDC) platform and can demonstrate it live — working proof of our ability to build metadata-driven eCRFs and reusable research workflows, not just a single fixed research tool.
Multi-Study Management
Study configuration, lifecycle management, timelines, status tracking, and administration across multiple concurrent research studies.
Dynamic eCRFs
Configurable forms with multiple field types, validation rules, conditional logic, sections, and versioning — built without modifying application code.
Participant Lifecycle
Enrollment, demographics, visit history, follow-up tracking, cohort management, and participant status tracking.
Research Workflows
Investigator and coordinator assignment, role-based access, permissions, department mapping, and visit scheduling.
Dashboards & Reporting
Study enrollment progress, participant status, visit compliance, data completion metrics, and exportable operational reports.
Governance & Audit
Role-based access control, activity logging, immutable audit history, schema versioning, and secure document storage.
Clinical Workflow
The 10-Step Clinical Research Workflow
The platform coordinates the complete clinical research journey from protocol initialization to study closeout.
Study Creation
Protocol & study setup
Team Assignment
PI & coordinator roles
Participant Enrollment
Cohort registration
Visit Scheduling
Timeline calendar
Dynamic eCRFs
Configured data forms
Clinical Capture
Point-of-care entry
Validation & QC
Rule & range checks
Monitoring
Status & queries
Analytics & Export
Structured data
Study Completion
Closeout & lock
Core Technical Differentiator
Metadata-Driven Dynamic eCRF Builder
This is one of the strongest technical capabilities of the platform. Forms are configured dynamically via metadata schemas rather than hardcoded pages — enabling research teams to create complex case report forms with validation rules, conditional logic, and versioning without deploying code.
Metadata-Driven Schema
Form layouts, sections, and questions are defined via JSON metadata rather than hardcoded templates.
Rich Field Type Library
Supports numeric, single-choice coded, multi-select, date/time, free text, and calculated fields.
Point-of-Capture Validation
Enforces required fields, data formats, min/max physiological ranges, and regex validation instantly.
Conditional Branching Logic
Dynamically shows or hides fields and sections based on prior question responses (e.g. AE follow-up).
Form Versioning & Migration
Maintains versioned eCRF definitions (v1.0, v2.0) ensuring in-flight participant data integrity.
Instant Live Preview
Real-time rendering engine allows research coordinators to test and preview forms before deployment.
Builder Scope: This is a clinical metadata-driven eCRF builder tailored for structured clinical research data collection and validation — not an unlimited generic website or no-code app creator.
Participant & Visit Management
Participant Lifecycle & Visit Matrix
Participants move through a structured clinical lifecycle: enrollment → cohort assignment → scheduled visits → eCRF point-of-care capture → investigator review & verification.
Participant Enrollment & Cohorts
Structured participant registration, demographic tracking, cohort assignment, and inclusion/exclusion verification.
Visit Schedule Tracking
Protocol-aligned visit timelines (Screening, Baseline, Follow-ups) with completion status and missed-visit alerts.
Investigator Review & QC
Integrated review drawer with point-in-time eCRF completion status, query management, and PI sign-off.
Study Administration
Multi-Study & Multi-Site Management
The platform is designed around a multi-study data model, allowing research organizations to manage multiple protocols, sites, and investigator teams simultaneously.
Study Configuration
Study details, phase, objectives, timeline, protocol numbers, and department mapping per trial.
Site & Team Allocation
Assign principal investigators, sub-investigators, study coordinators, and data managers per site.
Isolated Data Stores
Strict tenancy separation ensuring participant records and eCRF responses remain segregated per study.
Platform Architecture
End-to-End Clinical Data Flow & Governance Architecture
The platform separates study metadata definitions from transactional participant data, backed by cross-cutting role-based access control, schema versioning, and immutable audit logging.
Study Setup
Protocol Config
eCRF Metadata
Schema & Logic
Data Capture
Point-of-Care Entry
Validation Engine
QC & Range Rules
Secure Data Store
Relational DB
Reporting & Audit
Dashboards & Logs
CROSS-CUTTING PLATFORM GOVERNANCE & SECURITY CONTROLS
Investigator, Coordinator, Monitor & Data Team granular scopes
Timestamped logs of every data entry, modification, and query
Immutable form versions preserving retrospective study integrity
Operational Visibility
Dashboards & Study Reporting
Real-time dashboards provide study coordinators and research leadership with instant operational visibility across active trials.
Study Overview
Participant counts, target vs actual enrollment, active cohorts, and milestone timelines.
Visit Compliance
Scheduled, completed, upcoming, and overdue participant visit tracking across sites.
eCRF Completion Rates
Percentage of required forms submitted, pending validation, or flagged with queries.
Data Export
Standard structured data exports in CSV / JSON formats for downstream statistical analysis.
Security & Compliance
Security, Access & Governance
Role-Based Access Control
Granular permissions for Principal Investigators, Coordinators, Nurses, and Data Managers.
Data Protection
TLS in transit, encrypted storage at rest, and secure user session management.
Detailed Activity Logging
Timestamped records of participant creation, eCRF submissions, and data modifications.
Secure Documents
Encrypted storage for protocol documents, consent forms, and study documentation.
Scope & Compliance Note: This platform demonstrates configurable eCRFs, participant management, and structured clinical data capture. It is an engineering foundation and does not claim pre-certified compliance with 21 CFR Part 11, ICH-GCP, CDISC/SDTM, or formal HIPAA validation without organization-specific validation, SOPs, and deployment governance.
Tech Stack
Technology Stack
Frontend & Builder
React + TypeScript
Backend & Services
Node.js
Data Persistence
MySQL / PostgreSQL
Cloud Infrastructure
AWS
API Architecture
Modular REST APIs
Form Engine
Metadata-Driven Schema Engine
Applications
Where This Foundation Can Be Adapted
The architecture behind this EDC platform can be customized across various clinical research scenarios:
Investigator-led studies
Observational studies
Research registries
Longitudinal studies
Department research programs
Academic research platforms
Organization-specific workflows
These are adaptation possibilities based on the platform's configurable architecture — not a claim of readiness for pivotal, regulated drug trials without additional validation and compliance work.
What gets customized per engagement
Related Capabilities
Related Peerbits Capabilities
Healthcare Projects That Solve Real Technology Problems
Peerbits develops custom healthcare software solutions around your users, integrations, processes, data requirements, and long-term business goals.
Healthtech ,
Epic SMART on FHIR Integration
Peerbits designed a reusable interoperability demonstration connecting a React and Node.js application to Epic's FHIR R4 sandbox through SMART on FHIR authentication — proving real EHR connectivity, multi-resource retrieval, governed write-back, and a reusable FHIR client SDK.
See the Clinical Research EDC Workflow in Action
Walk through the working platform with our healthcare engineering team and explore how its eCRFs, participant workflows, study management and reporting architecture could be adapted to your research program.
