Electronic Data Capture (EDC) System

Capture, validate, and manage clinical trial data in one unified EDC system. Build and adapt studies with flexible configuration tools, manage data across sites and devices, and use Floyd, TrialKit’s AI model, to support study setup, validation, and analysis.

accessing TrialKit EDC on the web and the mobile app using a smartphone and a laptop
TrialKit EDC form builder displayed on desktop screen and on iPad screen
clinician using iPad for EDC in TrialKit

Clinical Trials Demand More From EDC Technology

Clinical research teams need EDC software that can accommodate complex protocols, support evolving study requirements, and give stakeholders timely access to reliable data.

TrialKit combines configurable electronic data capture with native mobile applications, integrated data management tools, and flexible study workflows. Teams can build, validate, deploy, and manage studies while maintaining control over how data is collected, reviewed, and analyzed.

With Floyd embedded in TrialKit, researchers can also use AI to assist with study configuration, test data generation, and analysis, extending the role of EDC across the clinical study lifecycle.

Person working with tablet in their lap, building eCRFs using TrialKit's form builder

What is an EDC System?

An electronic data capture (EDC) system is software used to collect, manage, and store clinical research data electronically. By replacing paper-based case report forms with digital data collection, EDC systems support timely data entry, automated validation checks, query management, and ongoing study monitoring.

TrialKit extends these capabilities with a unified, cloud-based environment accessible through the web and native applications for iOS, Android, and macOS. Research teams can collect data at clinical sites, support remote participation, and incorporate information from other TrialKit modules and external systems.

With configurable study designs, mobile access, and embedded intelligence through Floyd, TrialKit supports traditional site-based, hybrid, and decentralized clinical trials.

Why Choose TrialKit for Your EDC Needs?

TrialKit gives sponsors, CROs, and research teams greater control over study configuration, data collection, and ongoing data management. Its flexible architecture supports the requirements of individual studies while providing tools to manage changes, review data, and maintain oversight throughout execution.

Build and Validate with Floyd

Use Floyd to turn protocol requirements into configured eCRFs, complete with edit checks, conditional logic, and automated calculations. TrialKit’s built-in validation tools help teams test form behavior, document results, and review configurations before deployment.

Adapt to Protocol Amendments

Make controlled changes to study configurations as protocols evolve. TrialKit supports study versioning, testing changes before deployment, and migrating participants or sites to updated versions while data collection continues.

Manage Data Review and Monitoring

Support configurable review workflows, field-level source data verification, electronic signatures, and query management. Role-based review levels, batch review options, and monitoring reports help study teams track data review progress and maintain oversight.

Reuse Forms and Study Configurations

Build on existing work with reusable form libraries, field definitions, and conditional actions. Import previously validated forms into new studies, adapt configurations to specific protocols, and track validation status when changes are made.

Capture Data Across Web and Mobile

Collect and review study data through the web or TrialKit’s native mobile applications. Support site-based and remote data collection with device-flexible workflows that accommodate traditional, hybrid, and decentralized research.

Manage Multiple Studies and Sites

Access multiple studies through a single sign-on, with granular permissions and configurable access rights. Give sponsors, CROs, investigators, and site personnel access to the studies, forms, and functions appropriate to their roles.

Resolve Queries and Track Changes

Identify discrepancies through automated edit checks, manage data queries, and monitor their resolution. Detailed audit trails provide visibility into data changes and user activity, supporting data traceability throughout the study.

Access Data and Reports Throughout the Study

Monitor study activity, review data status, and access configurable reports as information is collected. TrialKit’s reporting capabilities help teams examine study progress and identify areas requiring attention.

FLOYD IN TRIALKIT EDC

Bring AI Into Your EDC Workflow With Floyd

Floyd is TrialKit’s AI model, developed with an understanding of the platform’s study configuration, data structures, and workflows. It helps clinical research teams work across study setup, validation, and data analysis within the TrialKit environment.

Floyd Working inside your TrialKit study
Generate CRFs and a visit schedule from this protocol.
Draft forms and a visit schedule are ready for your review.
Create synthetic participants to test the workflow.

ACROSS THE STUDY LIFECYCLE

STUDY SETUP

Build From Your Protocol

Use Floyd to interpret study requirements and assist with generating CRFs, visit schedules, and other study configuration elements. Teams can build from an existing protocol or use Floyd for individual tasks, such as generating forms from provided specifications.

CRFs Visit schedules Study configuration
VALIDATION

Test Before Going Live

Generate synthetic participant data to evaluate configured study workflows, test data collection scenarios, and investigate potential issues before live data collection begins.

Synthetic participants Workflow testing Issue investigation
DATA ANALYSIS

Explore and Analyze Study Data

Use Floyd to ask questions about study data and reports, examine patterns, and explore results that may warrant further review. These capabilities help extend data analysis and study oversight within TrialKit.

Data questions Reports Patterns and trends

Floyd supports study builders, data managers, and clinical teams while keeping human review and approval central to the process.

Study builders Data managers Clinical teams

From Study Configuration to Data Review

TrialKit brings the tools needed to configure, validate, capture, and review clinical research data into a unified environment.

Configure

Build CRFs, define visit schedules, establish edit checks, and set up study workflows.

Validate

Test form logic and configurations, document results, and use synthetic data to evaluate study scenarios.

Capture

Collect clinical data from sites, mobile devices, participants, and integrated data sources.

Review and Analyze

Manage queries, perform source data verification, monitor review status, and examine study data through reporting and Floyd-assisted analysis.

Extend EDC With TrialKit’s Unified eClinical Platform

Electronic data capture is one part of the clinical research workflow. TrialKit brings EDC together with additional eClinical capabilities in a unified platform, helping teams manage related study activities and data without relying on multiple disconnected systems.

TrialKit shown on a laptop, iPad, iPhone, and Apple Watch
Research team collaborating on a laptop in clinical setting

Who Benefits From TrialKit EDC?

TrialKit supports clinical research teams with different study responsibilities, giving each group access to configurable tools and workflows that align with their roles.

  • Sponsors: Maintain visibility into study progress, manage data across sites, and retain greater control over database configuration and amendments.
  • Contract Research Organizations (CROs): Manage multiple studies and sponsors, reuse established study configurations, and support consistent data management processes across research programs.
  • Investigators and Research Sites: Enter and review study data through accessible web and mobile interfaces, manage assigned activities, and participate in electronic review and sign-off workflows.

See How TrialKit Can Support Your Next Study

From protocol-driven study configuration to data collection, validation, and analysis, TrialKit gives your team the tools to manage clinical research data within one unified environment.

See how TrialKit EDC and Floyd can support your study requirements while giving your team greater flexibility and control throughout execution.

FAQs About Electronic Data Capture

What is an EDC system?

An electronic data capture (EDC) system is software used to electronically collect, manage, and store clinical research data. It typically includes electronic case report forms (eCRFs), data validation rules, query management, audit trails, and reporting tools that support data quality and study oversight.

What is the role of an EDC system in clinical trials?

In clinical trials, EDC systems serve as the central hub for collecting patient-reported outcomes, lab results, and case report forms. They enable faster data review, support regulatory compliance, and improve the overall efficiency of the study process.

How is TrialKit different from traditional EDC software?

TrialKit combines configurable EDC with native mobile applications, study version management, automated eCRF validation, data review workflows, and additional eClinical modules in a unified platform. Floyd extends these capabilities with AI assistance for study building, testing, and data analysis.

Can TrialKit accommodate protocol amendments after a study goes live?

Yes. TrialKit supports controlled study versioning, allowing teams to configure and test changes before moving participants or sites to updated study versions. This helps teams accommodate protocol amendments while managing ongoing data collection.

How does Floyd support EDC study building and validation?

Floyd can interpret protocols and assist with generating CRFs and visit schedules. It can also help generate synthetic study data for testing and support analysis of study reports and data. These capabilities complement TrialKit’s existing configuration, validation, and data management tools.

How does TrialKit support clinical data quality and regulatory requirements?

TrialKit provides configurable edit checks, electronic audit trails, role-based permissions, data review workflows, and electronic signatures to support controlled clinical data management. Appropriate study configuration, validation, and operational procedures remain important for meeting applicable regulatory requirements.

Is TrialKit suitable for both small and large clinical studies?

TrialKit supports studies of varying sizes and complexity, from smaller research projects to multinational clinical trials. Configurable workflows, study permissions, mobile access, and unified platform capabilities allow teams to tailor the environment to their research requirements.

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