Electronic Data Capture (EDC) is a system for recording and maintaining subject data in clinical trials. These systems capture electronic records, including electronic case report forms (eCRF), electronic patient-reported outcomes (ePRO), and data from integration with medical devices, e.g., electrocardiogram (ECG).
EDC systems started to gain traction in the early 2000s, replacing paper-based forms with electronic ones. Over time, clinical trials have become more complex, and EDC systems have evolved to meet changing clinical research needs. EDC standards were developed to protect the system’s patients and users and ensure accuracy, reliability, and consistent intended performance.
Regulatory agencies like the Food and Drug Administration (FDA) require procedures and controls for EDC system validation, internal and external security safeguards, and audit trails.
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The Benefits and Challenges of EDC
Benefits of EDC
A recent study by Tate & Smallwood (2021) compared the efficiency of traditional paper-based data capture and EDC during in-person interviews and found that EDC can reduce errors, increase efficiency, and decrease cost, without compromising the randomized, stratified nature of the survey in question.
In addition, EDC ensures data quality through standardized input, automated audit trails, data security, integration with other software and systems to transfer data validly, quickly, and reliably, and compliance with regulatory requirements.
Past Challenges
Early-generation EDC systems tended to be developed in isolation and to support specific parts of the clinical trial process, which eventually led to redundancies.
Maintaining and getting disparate systems to work together was inefficient and hampered the effective use of data for patient management. Longer trials faced the problem of maintenance and keeping EDC systems updated and integrated with other systems.
Streamlining Patient Management
The Vial Technology Platform leverages connected data and intuitive systems to run global trials efficiently at scale.
Vial enables more efficient trials through a connected, end-to-end software suite that comprises the site startup portal, digital visit capture, and study analytics dashboard.
With years of experience and firsthand knowledge facing the limitations of legacy clinical trial systems, Vial’s technology team of software engineers and designers has reimagined clinical trials and built a single compliant and connected system for data capture and review.
The team lead, Luke Bogus, joins Vial from Microsoft, armed with experience in large-scale data analysis infrastructure and applications.
Vial eClinical
To fit the unique needs of your clinical trial, Vial’s eClinical platform, powered by the Vial EDC, provides a full clinical trial technology suite. The Vial custom software suite includes EDC, direct data capture (DDC), ePRO, electronic clinical outcome assessment (eCOA), and eConsent. With Vial eSource data and an integrations platform, Vial offers you a single home for your study and patient data.
Vial Site Onboarding App: Fast, self-service, and digital-first onboarding
Are you frustrated by onboarding delays and having to sift through email threads while worrying about outdated document transfer and approval processes?
The Vial Site Onboarding App was created by experts who suffered and dealt with the same issues and sought to eliminate them. Vial simplifies and accelerates site activation through a digital-first approach to managing startups, from RegPacket to clinical trial agreement (CTA).
Self-service onboarding is done entirely digitally for sites. You will enjoy real-time editing when needed and zooming out to a bird’s eye view to track site-by-site startup statuses.
The Vial Site Onboarding App fully integrates with Vial’s preferred electronic Trial Master File (eTMF), Egnyte eTMF, enabling quick and compliant document structuring and storage. Vial’s cloud-based site startup enables simple onboarding for sites in as few as 30 days.
Vial Electronic Data Capture (EDC): Compliant, encrypted, and secure
In the past two decades, clinical trials have become more complex. Clinical research teams trying to manage the growing volume of data, number of data sources, and varied types of data as well as unstructured data, e.g., from wearable tech, might need help with older EDC systems designed mainly to support structured electronic forms.
Built on a cloud-native infrastructure, Vial’s EDC brings consumer-grade experience and performance to eClinical software. Connected data capture and review enables higher-quality results. As a fully-encrypted and compliant platform (21 CFR Part 11, HIPAA, GDPR), the Vial EDC is the core of Vial’s eClinical technology suite and checks off your boxes for
- Fast database and eCRF build timelines (~4 weeks)
- Full-feature EDC system that is designed for
- User management: user management is driven by robust user-permissions and data access model
- Patient management: simple subject and visit management, easily visualizing procedure-, visit-, and subject-based status
- Usability: intuitive eCRF data input, with built-in data validations and rules logic
- Audit trail: end-to-end audit trail, logging all data actions and edits for each data point
- Data management: Full data management suite includes queries, source data verification (SDV), reviews, freeze, signature, and lock. Data export capabilities of eCRFs, query logs, audit logs, and more
Unlike past clinical trials, which were supported by separate systems, Vial supports clinical research through a compliant and connected system for real-time higher-quality data collection, which is faster, easier, and cheaper. Ultimately, the Vial EDC supports study teams with data on the efficacy of an intervention to make timely and informed decisions.
Vial eSource: Driving radical changes in trial workflows
With your needs firmly in mind, Vial eSource’s innovative solution further embeds technology within trial conduct to enable real-time data capture and review – all in one cohesive system.
Vial eSource is powered by:
- Vial Direct Data Capture (DDC)
- Direct-to-EDC eliminates onerous double data entry for sites
- Intuitive user experience enables simple, real-time data input
- Reduces protocol deviations for sites
- Vial Tablets are shipped directly to sites and cloud-managed by Vial, or sites have the option to provide their own devices
- Vial Data Platform
- Robust data platform to ingest and structure data from multiple sources into Vial EDC
- Customizable vendor integrations between labs, imaging, EMR, and your study-specific systems
- Flexible automatic data ingest engine via API, .csv, flat file, STFP, email, and more.
Vial ePRO, eCOA, eConsent
Built on the same engine as Vial’s DDC technology, Vial provides easy-to-use and compliant ePRO, eCOA, and eConsent solutions.
Vial Integration Platform
Vial’s next-gen eClinical technology infrastructure enables integration with 3rd party systems, such as interactive response technology (IRT), where 4G Clinical is Vial’s preferred, pre-integrated IRT solution (with the flexibility to integrate with others) and custom integrations required for your trial, such as Lab Portals, Imaging Portals, and more.
Vial Study Analytics Dashboards: Real-time data, fully customized to your study
Stay connected and informed with Vial Study Analytics Dashboards. Vial’s digital-first approach to data capture enables Vial, sites, and our sponsors to monitor study progress, milestones, and outcomes in near-real-time.
The Vial database aggregates data across Vial’s Site Onboarding App, eClinical technology, and internal contract research organization (CRO) project management and tracking systems.
Built on a highly-customizable analytics platform, our dashboards provide the following:
- Study Milestone Tracking, which includes site and study startup progress, subject enrollment progress, protocol deviations, and adverse event (AE)/serious adverse event (SAE) monitoring
- Study Data Monitoring of subject visit statuses and target visit dates, data cleaning and lock progress reports, and query statuses and aging reports
- Complete customization to the needs of your study and KPIs that matter most to you
All dashboards can be accessed 24/7 via Vial’s dashboard web portal, accessible only through unique login credentials for sites, sponsors, and approved additional stakeholders.
Why Vial EDC?
Below we list six reasons why biotech companies should choose to use Vial’s EDC and full technology platform.
1. Global Standards
Leveraging the expertise and hands-on experience of Vial’s tech team of software engineers and designers, the Vial EDC is built on 21st-century technology and infrastructure – global-ready with built-in data protection. The Vial EDC establishes user permission and roles to lock down data access to relevant users and sites and has comprehensive audit logging for all relevant study data. Vial EDC is compliant with FDA 21 Code of Federal Regulations (CFR) Part 11, Health Insurance Portability and Accountability Act (HIPAA), and General Data Protection Regulation (GDPR) and adheres to the International Council for Harmonisation of Technical Requirements for Pharmaceuticals for Human Use (ICH) Guideline for Good Clinical Practice (GCP) E6(R2) standards.
2. Understanding and Responding to your needs
The in-house Vial tech team helps Vial dedicate engineers to your trial while having end-to-end control over the technology ensures you receive data-on-demand in formats you require. The Vial EDC goes toe-to-toe with the big players in the market and has all the EDC features you would expect: Clinical Data Acquisition Standards Harmonization (CDASH)/ Study Data Tabulation Model (SDTM) on-entry eCRFs, full query management, audit logs and locks, data and report exports, and customizable dashboards.
3. Ease of Use
The purpose-built Vial technology, including the EDC and eSource described above, makes it easy to collect and check data quickly. The cloud-based/tech-enabled system allows data monitoring in real-time and supports data management practices.
4. Database Build Timelines are short
Upon receiving the study protocol, the Vial team thinks critically up-front about the user experience, the data to be captured, and how the data will conform to the system. This helps ensure better alignment, reduces changes during the study, reduces entry error, and provides the collection of higher-quality data. The team establishes review periods and arranges review meetings, develops an eventual data validation and testing plan, and aligns on timelines. Once approved, the Vial in-house team of software engineers make customized changes and, to expedite the process, have built a simple, flexible, and quick eCRF builder to allow for simple changes. Rapid feedback allows the team to make easy edits. Testing by the Vial team is two-fold – first deploying a suite of automated system unit tests used for all Vial trials (e.g., bug checks, system penetration, and data safety tests), and then additional validation through user acceptance testing (UAT) and edit checks. Once testing is complete, align on final timelines, sign off on UAT and DB readiness, and discuss the data management plan before going live!
5. Data Management (DM) Strategies fueled by fast-performing & integration-ready Vial EDC
For optimal design based on the tenet of high-quality data input leading to high-quality data, the Vial team plans for eCRF per Clinical Data Interchange Standards Consortium (CDISC) and SDTM standards, built-in skip logic, and on-entry data validation (rules-based system, value ranges to flag issues before a query happens). For cleaning, having higher quality data is ideal, followed by a simple query flow and filter/sort options to quickly SDV data points or create/respond to queries. The Vial team performs ongoing reconciliation of vendor data, medical coding, and SAE monitoring. For detailed reporting, the standard BI data visualization platform allows users to create custom views.
6. Vial Data Management and Biometrics Leadership
The Vial in-house DM team is deeply involved in system design and EDC build. It conducts ongoing data management and cleaning and statistical analysis during the trial and throughout closeout. The Vial DM team collaborates closely with biostat partner, Veranex, to fully manage, review and validate all documents, datasets, and TFLs (tables, listings, and figures) before sending them to you.
The CRO for Biotech, Powered by Technology
Vial is a next-generation, tech-first CRO delivering faster, more efficient trials at dramatically lower costs for biotech sponsors. Our mission is to empower scientists to discover groundbreaking scientific therapeutics that help people live happier, healthier lives.
We are more than just a CRO — we are “doers” — innovators, engineers, and ClinOps leaders. We have built a global, full-service CRO powered by intuitive end-to-end technology.
The Vial technology platform has been deployed at scale in more than ten trials (active or starting) in five therapeutic areas across more than 125 sites in more than 25 countries.
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