Electronic Data Capture (EDC) System

Modern clinical trials require modern technology. Leverage the flexibility and speed of the cloud with TrialKit.

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

Neither traditional nor hybrid clinical trials can operate on rigid EDC systems.

They require flexible data collection systems that support protocol amendments without downtime and accept mobile data without hassle. As a cloud-native solution, TrialKit bends to accommodate mid-study changes. And as the first full-featured EDC platform available as a native mobile app, TrialKit flexes to meet the demands of traditional, hybrid/decentralized, and completely remote clinical trials.

Give your team the freedom to build, deploy, and manage their studies, their way—weeks faster than with rigid EDCs and for a fraction of the cost of the major players.

What is an EDC System?

An Electronic Data Capture (EDC) system is a digital platform used in clinical trials to collect, manage, and store clinical data. Unlike traditional paper-based methods, which are prone to delays, transcription errors, and logistical hurdles, EDC systems enable real-time, secure data entry and monitoring from any location.

TrialKit goes beyond basic data capture. It’s a fully mobile, cloud-based system that empowers researchers to collect data directly from sites, patients, or wearable devices—anytime, anywhere. With native mobile apps for iOS, Android and Mac, TrialKit supports decentralized, hybrid, and site-based studies, setting it apart from traditional web-only EDC platforms.

Who Benefits From EDC?

Electronic Data Capture systems streamline data collection and management across a wide range of clinical research stakeholders. Whether you’re running a small pilot study or a large multinational trial, EDC systems like TrialKit can scale to fit your needs. Those who benefit include:

Clinical Research Organizations (CROs) – Simplify study builds, manage multiple trials, and ensure high data quality across sponsors.
Pharmaceutical and Biotech Companies – Gain faster insights, improve compliance, and accelerate time to market.
Independent Investigators and Academic Researchers – Access an affordable, self-configurable system with powerful tools, perfect for limited budgets.
Sponsors and Study Coordinators – Monitor progress in real time, reduce site burden, and drive operational efficiencies across global trials.

TrialKit’s flexible licensing, scalability, and end-to-end capabilities make it an ideal fit for organizations of all sizes.

Why Choose TrialKit for Your EDC Needs?

TrialKit EDC’s flexible, configurable architecture adjusts with your protocol amendments, making it easy to add cohorts and sites, modify dosing regimens, and more. Rigid systems don’t have this functionality.

Make mid-study changes with zero downtime

No more hair-puller days spent fighting your EDC. No more time-consuming migrations. Make study modifications with the click of a button.

Multiple studies, single sign-on

Sponsors and sites have controlled access to all studies—via web or mobile app—with one sign-on.

Easy eCRFs

Move field variables anywhere on the form using drag-and-drop functionality in TrialKit’s universal design tool. Create edit checks and annotated PDFs, export form data dictionaries, and more.

Reuse and repurpose forms and study builds

Save weeks off study builds by repurposing forms, variables, and conditional actions. Replicate and repurpose any study across multiple accounts from anywhere.

Secure site management

With control of 250 permissions and form access rights throughout the system, you can give sites and users only as much access as they need.

Integrated query management

Perform queries via the web or mobile app or use system-generated queries from data updated in real time. View complete audit trails to monitor study risk.

Seamless Integration with Other TrialKit Products

TrialKit shown on a laptop, iPad, iPhone, and Apple Watch

How an EDC System Improves Clinical Trials

An EDC system brings efficiency, accuracy, and compliance to clinical trials, transforming the way data is collected and managed. TrialKit enhances these benefits with mobile-first technology, real-time analytics, and unified integration with other critical study tools.

Increases Trial Efficiency

By enabling real-time, remote data entry and monitoring via mobile devices, TrialKit accelerates data collection and reduces site visits, streamlining trial workflows. Learn more.

Reduces Errors and Improves Data Accuracy

Built-in data validation checks flag discrepancies at the point of entry, ensuring high-quality data throughout the study lifecycle. TrialKit also has direct data capture (DDC) tools to minimize transcription errors. Read about integrating DDC with EDC.

Enhances Compliance

With features like audit trails, role-based access, and compliance with FDA 21 CFR Part 11, HIPAA, and GDPR, TrialKit helps ensure your trial meets regulatory requirements. Explore the basics of EDC compliance.

Get Started with TrialKit Today

FAQs About EDC

What is an EDC system?

An Electronic Data Capture (EDC) system is a digital platform used in clinical trials to collect, manage, and store patient data. It replaces traditional paper-based methods, allowing researchers to enter and review data in real-time from any location.

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.

Is an EDC system secure?

Yes, TrialKit is highly secure. It uses data encryption, access controls, audit trails, and compliance with HIPAA, GDPR, and FDA 21 CFR Part 11 to protect sensitive clinical trial information.

Can an EDC system be used in decentralized or hybrid trials?

Absolutely. EDC systems are especially valuable in decentralized and hybrid trials because they allow data to be collected remotely via mobile devices, wearable tech, or home visits, supporting patient engagement and real-time data access.

How easy is it to use an EDC system?

TrialKit offers a universal design tool for drag-and-drop form building, mobile compatibility, and intuitive dashboards, making it accessible even to teams with minimal technical experience.

Is an EDC system scalable for large or multinational studies?

Yes, EDC systems are highly scalable and can support everything from small pilot studies to large, global Phase III and IV trials. Features like multilingual support, cloud-based access, and flexible data structures allow for seamless expansion.

How does an EDC system improve compliance?

EDC systems improve compliance by providing electronic audit trails, automatic data validation, and secure access control. These features help ensure that all data handling meets FDA and international regulatory requirements.

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