Peerbits Engineering Use Case · ClinTrial EDC
Configure studies and eCRFs, manage participants and visits, capture structured clinical data, and maintain visibility and traceability from one unified research platform.
Clinical research management & electronic data capture
Investigators, coordinators, research nurses & data teams
Metadata-driven eCRFs + configurable workflows
Multi-study & multi-site architecture
RBAC, schema versioning & immutable audit history
Working demonstration available
The Challenge
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.
Paper case report forms and ad-hoc spreadsheets lead to transcription errors, missing mandatory fields, and varying form schemas between research sites.
Participant demographics, visit calendars, and lab observations stored in disparate tools without a single, synchronized source of truth.
Difficult to reconstruct the exact history of who entered or changed clinical observations, when edits occurred, and why values were updated.
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
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.
Study configuration, lifecycle management, timelines, status tracking, and administration across multiple concurrent research studies.
Configurable forms with multiple field types, validation rules, conditional logic, sections, and versioning — built without modifying application code.
Enrollment, demographics, visit history, follow-up tracking, cohort management, and participant status tracking.
Investigator and coordinator assignment, role-based access, permissions, department mapping, and visit scheduling.
Study enrollment progress, participant status, visit compliance, data completion metrics, and exportable operational reports.
Role-based access control, activity logging, immutable audit history, schema versioning, and secure document storage.
Clinical 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
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.
Form layouts, sections, and questions are defined via JSON metadata rather than hardcoded templates.
Supports numeric, single-choice coded, multi-select, date/time, free text, and calculated fields.
Enforces required fields, data formats, min/max physiological ranges, and regex validation instantly.
Dynamically shows or hides fields and sections based on prior question responses (e.g. AE follow-up).
Maintains versioned eCRF definitions (v1.0, v2.0) ensuring in-flight participant data integrity.
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
Participants move through a structured clinical lifecycle: enrollment → cohort assignment → scheduled visits → eCRF point-of-care capture → investigator review & verification.
Structured participant registration, demographic tracking, cohort assignment, and inclusion/exclusion verification.
Protocol-aligned visit timelines (Screening, Baseline, Follow-ups) with completion status and missed-visit alerts.
Integrated review drawer with point-in-time eCRF completion status, query management, and PI sign-off.
Study Administration
The platform is designed around a multi-study data model, allowing research organizations to manage multiple protocols, sites, and investigator teams simultaneously.
Study details, phase, objectives, timeline, protocol numbers, and department mapping per trial.
Assign principal investigators, sub-investigators, study coordinators, and data managers per site.
Strict tenancy separation ensuring participant records and eCRF responses remain segregated per study.
Platform 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
Real-time dashboards provide study coordinators and research leadership with instant operational visibility across active trials.
Participant counts, target vs actual enrollment, active cohorts, and milestone timelines.
Scheduled, completed, upcoming, and overdue participant visit tracking across sites.
Percentage of required forms submitted, pending validation, or flagged with queries.
Standard structured data exports in CSV / JSON formats for downstream statistical analysis.
Security & Compliance
Granular permissions for Principal Investigators, Coordinators, Nurses, and Data Managers.
TLS in transit, encrypted storage at rest, and secure user session management.
Timestamped records of participant creation, eCRF submissions, and data modifications.
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
Frontend & Builder
Backend & Services
Data Persistence
Cloud Infrastructure
API Architecture
Form Engine
Applications
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.
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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.
