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SmartSource™ Platform

One platform. Direct source data. Faster database lock.

SmartSource™ captures clinical data directly from investigators and patients—eliminating transcription, reducing queries, and giving you real-time visibility into your trial.

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Traditional clinical technology creates problems, not solutions

Most sponsors piece together multiple systems from different vendors. EDC from one company. CTMS from another. Separate tools for ePRO, randomization, and document management. The result? Data silos, integration headaches, and no single source of truth.

Multiple Systems

Traditional trials require 5-7 separate technology vendors. Each system stores data differently. Each integration point creates risk.

Transcription Errors

Paper source documents get transcribed into EDC. Every keystroke introduces error potential. Every error generates queries.

SDV Burden

CRAs travel to sites to verify source data against EDC entries. Expensive. Time-consuming. Adds weeks to your timeline.

SmartSource eliminates these problems by design.

A unified platform built for direct source data capture

SmartSource™ is Validcare's proprietary clinical trial platform. Unlike traditional eClinical systems that bolt together separate tools, SmartSource was designed from the ground up as a single, integrated platform where source data is captured directly—at the point of care.

Everything you need. Nothing you don't.

SmartSource includes all the clinical technology capabilities your trial requires—integrated into a single platform with unified data, workflows, and reporting.

CTMS

Clinical Trial Management System

  • Feasibility tracking
  • Site management
  • Milestone tracking
  • Budget monitoring

Digital Recruitment

Patient recruitment and screening

  • Digital advertising integration
  • Prescreening workflows
  • Source tracking
  • Performance analytics

eConsent

Electronic informed consent

  • Remote or in-person
  • Version control
  • 24/7 audit trail
  • Multi-language support

Randomization/IRT

Interactive Response Technology

  • Treatment assignment
  • Stratification
  • Drug supply management
  • Blinding maintenance

EDC (eCRF)

Electronic Data Capture

  • Direct source entry
  • Edit checks
  • Query management
  • Audit trail

ePRO

Electronic Patient-Reported Outcomes

  • Patient diaries
  • Symptom tracking
  • Compliance monitoring
  • Reminders and alerts

eCOA

Electronic Clinical Outcome Assessments

  • Clinician assessments
  • Observer assessments
  • Performance outcomes
  • Validated instruments

Vendor Data Integration

Third-party data

  • Central lab results
  • Imaging data
  • Wearable/device data
  • External system feeds

AE/SAE - PV Workflow

Safety management

  • Adverse event capture
  • SAE workflows
  • Regulatory reporting
  • Medical review queues

Protocol Deviations

Deviation management

  • Capture and classification
  • Root cause tracking
  • CAPA management
  • Reporting

eTMF/eISF

Electronic Trial Master File

  • Document repository
  • eISF for sites
  • Delegation of Authority
  • Inspection-ready

Investigator Training

Site training and certification

  • Training modules
  • Certification tracking
  • Digital binder
  • Compliance monitoring

Data captured at the source. Queries eliminated before they start.

The fundamental difference between SmartSource and traditional eClinical systems: we capture data directly from the person who knows it—the investigator or the patient—at the moment it's created.

Traditional Approach
  1. 1 Investigator records data on paper source document
  2. 2 Data transcribed into EDC by site staff
  3. 3 Transcription errors generate queries
  4. 4 CRA travels to site for SDV
  5. 5 Queries resolved over weeks/months
  6. 6 Database lock delayed
vs
SmartSource Approach
  1. 1 Investigator enters data directly into SmartSource
  2. 2 Edit checks validate in real-time
  3. 3 Data flows clean to sponsor
  4. 4 No transcription = no transcription errors
  5. 5 No SDV visits required
  6. 6 Database lock in days

Key Benefits

Significantly Fewer Queries

No transcription means no transcription errors. Real-time edit checks catch issues at entry. Queries that would take weeks to resolve never exist.

Elimination of SDV

When source data IS the EDC data, there's nothing to verify. SDV visits—and their costs—disappear.

Faster Database Lock

Continuous data cleaning throughout the study. No backlog of queries at study end. LPLV to DBL in days, not months.

Lower Data Management Costs

Fewer queries to manage. No SDV travel. Reduced CRA overhead. Technology does the work.

The right data, for the right people, at the right time

SmartSource provides role-based access tailored to each user's needs. Investigators see their patients. Sponsors see the whole trial. Everyone sees what they need—in real time.

For Sponsors

  • Real-time enrollment dashboards
  • Data quality metrics
  • Site performance comparisons
  • Financial and milestone tracking
  • AE/SAE reporting
  • Protocol deviation summaries

For Investigators

  • Patient visit schedules
  • Case report forms
  • Lab result entry
  • AE/SAE capture
  • Regulatory document access
  • Payment tracking

For Patients

  • ePRO diaries
  • Visit reminders
  • Medication logs
  • Symptom reporting
  • Appointment scheduling
  • eReimbursement

For Validcare Team

  • Central monitoring dashboards
  • Query management
  • PV workflows
  • Site support tools
  • Risk indicators
  • Performance analytics

Your trial. Your dashboard. Real-time.

Traditional CROs give you monthly reports compiled from stale data. SmartSource gives you live dashboards that update as data enters the system.

Enrollment Tracking

  • Screening vs. enrollment rates by site
  • Recruitment funnel visualization
  • Enrollment projections
  • Site activation status

Data Quality

  • Query rates by site and form
  • Data entry completion
  • Outstanding items
  • Cleaning status

Safety Monitoring

  • AE/SAE summaries
  • Reporting timelines
  • Medical review status
  • Regulatory submission tracking

Financial & Operational

  • Budget vs. actual
  • Milestone achievement
  • Site payment status
  • Change order tracking

No black boxes. No waiting for reports. No surprises.

Built for regulatory inspection. Designed for data security.

21 CFR Part 11
GDPR Compliant
Data Security

21 CFR Part 11

  • Electronic signatures with full attribution
  • Complete audit trails
  • System access controls
  • Data integrity safeguards
  • Validation documentation

GDPR

  • Data subject rights management
  • Consent tracking
  • Data minimization
  • Cross-border transfer compliance
  • Right to erasure support

Data Security

  • Encrypted data at rest and in transit
  • Role-based access controls
  • Multi-factor authentication
  • Regular security audits
  • Disaster recovery

Complete Audit Trail

Every action in SmartSource is logged with timestamp, user ID, and before/after values. Complete, immutable, inspection-ready.

Plays well with others when needed

SmartSource handles most trial needs natively. When you need external systems, we integrate seamlessly.

Central Labs

  • Automated lab result import
  • Reference range flagging
  • Alert generation

Imaging

  • DICOM integration
  • Image repository
  • Reader workflows

Wearables & Devices

  • Connected device data capture
  • Sensor data integration
  • Compliance monitoring

External Systems

  • Sponsor data warehouses
  • Safety databases
  • Regulatory submission systems
See It For Yourself

Ready to see how SmartSource works?

Schedule a demo and we'll walk you through the platform—with your protocol in mind.

hello@validcare.com +1 844 825 4322

Include details about your therapeutic area, patient population, and timeline.