Electronic Data Capture (EDC) Systems

Medical devices and supplies on laboratory table

Role of EDC Systems

During clinical trials, data quality and study efficiency are of the utmost importance. Electronic Data Capture (EDC) software helps sponsors collect trial data and manage processes including patient form design, medical coding, and source data verification. Prior to EDC, clinical trial data was documented on 3- part NCR paper, which was liable to various pain points. Data captured incorrectly at the source, forms delayed in transit, and inefficiency in back-and-forth communication were just a few challenges that sponsors faced. Nowadays, life sciences organizations typically capture data electronically at the source (“e-source”) or transcribe paper forms into an EDC system.

Benefits of EDC Systems

Build Studies Efficiently

A well-designed centralized EDC supports global libraries, enabling reuse of data across studies. With an intuitive, user-friendly interface, data managers may create and review studies as soon as the protocol is approved. Protocol amendments may be implemented with no system downtime thanks to advanced tools.

Run Complex Trials

As pipeline grows, so does the complexity and number of trials. While legacy EDC relies heavily on custom functions and external data verification checks, modern EDC systems offer built-in form edit checks and direct data entry to significantly reduce source data verification efforts. EDC reporting capabilities and search filters allow Sponsors, Sites and CROs to quickly assess study progress. Many EDC solutions can even be configured to effectively accommodate studies across different therapeutic areas.

Enhance Data Quality and Accessibility

Many vendors enable integrations to connect EDC with CTMS, safety databases, RTSM, and ePRO to establish a single source of truth. Not only can EDC absorb data from a large range of sources, but it also allows repurpose of this data downstream. Trial processes are simplified; once researchers log in with secure credentials and fill out the relevant eCRF, sponsors may review study progress in real time. With a centralized platform, protocol violations and out-of-range values are addressed before they influence the outcome of the study.

EDC Operational Models

Sponsors often consider whether to take an EDC in-house or partner with a CRO. While this decision depends on the unique Sponsor and study, here are general benefits of each operational model. 

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In-House EDC System

  • Customization: Sponsors directly decide the EDC system setup and functionality; in turn, they are responsible for validation and maintenance 
  • Data Autonomy: because the Sponsor owns the system, access and control of data abides by your organization’s standards and your organization only 
  • Speed: In-house EDCs eliminate external communication bottlenecks; once trained, Sponsor personnel may pull study information and analyze without needing to consult outside parties 
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Outsourced EDC System

  • Expertise: CROs have established experience, infrastructure, and resources to run efficient studies, allowing Sponsors to focus on more critical aspects of clinical operations 
  • Cost Efficiency: CROs offer competitive pricing through fixed contracts (however, post-production changes to the protocol can quickly result in change orders and cost escalation) 
  • Agility: CROs can quickly deploy EDC systems across multiple studies. ProPharma can work in a variety of systems depending on your study’s phase and therapeutic area 

EDC User Roles

Sponsors, contract research organizations (CRO), and sites play critical roles in clinical data collection. Common EDC roles include:

  • Study Builders
  • System Administrators
  • Data Managers
  • Clinical Research Coordinates
  • Clinical Research Administrations
  • Study Investigators
  • Medical Coding
  • Inventory Control
  • Biostatistics
Woman in lab coat typing on laptop in a lab
Woman technician looking into microscope

A robust EDC platform supports them in the following day-to-day tasks

Sponsor/CRO

  • Designing customized study forms (eCRF)
  • Performing Validation and/or User Acceptance Testing, both at the system and study level
  • Training sites on using the EDC for each specific study
  • Overseeing studies to ensure compliance with protocols, Good Clinical Practices, and all applicable regulations
  • Monitoring data collection for discrepancies
  • Reviewing source documentation and case report forms
  • Analyzing data metrics as requested by Sponsor
  • Submitting queries to sites to resolve trial issues

Site

  • Entering participant information, such as research data and patient’s background
  • Reviewing and processing clinical trial data
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Electronic Data Capture Support

Partner with ProPharma to optimize your clinical trials using their advanced Electronic Data Capture (EDC) solutions. Leverage ProPharma's expertise to ensure seamless data management, enhance study efficiency, and improve data quality with their comprehensive EDC support. Contact ProPharma today to elevate your clinical data capture processes and drive successful trial outcomes.

EDC System Agnostic

It’s critical that EDC solutions provide features that streamline processes for each user group. There are numerous EDC vendors in the life sciences space, all of which generally provide study build tools, customizable eCRFs, and data analytics. Below, we’ve listed some solutions that our clients use.

Popular EDC Systems

Medrio EDC (Medrio)

Medrio's user-friendly, scalable, and cloud-based solution offers reusable templates to build studies faster.

Medrio EDC (Medrio)

Medrio's user-friendly, scalable, and cloud-based solution offers reusable templates to build studies faster.

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OpenClinica EDC (OpenClinica)

OpenClinica enables randomization from directly within eCRFs, mobile-friendly interface, intelligent reporting, and data import via batch upload or API.

OpenClinica EDC (OpenClinica)

OpenClinica enables randomization from directly within eCRFs, mobile-friendly interface, intelligent reporting, and data import via batch upload or API.

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Rave EDC (Medidata, Dassault Systemes)

With 30,000+ clinical trials ran, Rave EDC is a cornerstone of the Medidata Platform. It unifies key features such as Rave Coder for medical coding, Rave Safety...

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Rave EDC (Medidata, Dassault Systemes)

With 30,000+ clinical trials ran, Rave EDC is a cornerstone of the Medidata Platform. It unifies key features such as Rave Coder for medical coding, Rave Safety Gateway for ICH E2B format transmission, and Medidata TSDV for clinical monitoring.

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Vault EDC (Veeva Systems)

Adopted by 100+ organizations, Vault EDC can consolidate with other applications in the Vault Clinical Operations Suite: CDB, CTMS, RTSM, ePRO, and Payments to improve the...

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Vault EDC (Veeva Systems)

Adopted by 100+ organizations, Vault EDC can consolidate with other applications in the Vault Clinical Operations Suite: CDB, CTMS, RTSM, ePRO, and Payments to improve the clinical trial process. Explore ProPharma's Veeva Vault Support Capabilities.

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Zelta (Merative)

Zelta’s key features include data integration, query management, study-level reporting, and monitoring tools that are tailored towards both CROs and Sponsors.

Zelta (Merative)

Zelta’s key features include data integration, query management, study-level reporting, and monitoring tools that are tailored towards both CROs and Sponsors.

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5 Important Factors in Selecting an EDC

Before contacting vendors, it’s important to collect the following information about your organization:

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Business Requirements

Business Requirements

regulatory-operations

Budget

Budget

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Timeline

Timeline

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Complexity

Complexity

quality-compliance

Compliance

Compliance

Business Requirements

EDC solutions are not one-size-fits-all. Determine which features are nice-to-have, and which ones are critical for your organization. For example, if CTMS integration and no coding are requirements, confirm that potential vendors will support those needs.

Several hands pointing to Tablet device and writing in notebooks

Budget

EDC systems should be viewed as an investment. Licensing, system support, and subscription fees may be continuing costs that should be compared against your department’s budget. Consider how pricing may change as you build more studies and add system users.

Professional workers collaborating in an office

Timeline

Consider each vendor’s proposed implementation timeline against the time constraints of your company. If a critical study is starting in eight weeks, narrow consideration down to vendors who can complete the project in that timeframe.

Women working in conference room discussing various data and charts

Complexity

Purchasing an EDC is an investment not only of money, but also of time and effort. How much training will your staff need to learn the system properly? Additionally, factor in your team’s adaptability and buy-in when selecting a particular solution.

Health care provider writing on clear whiteboard

Compliance

Does the EDC software meet all requirements imposed by HIPAA, GDPR, and 21 CFR Part 11? Assess the vendor’s agility in releasing new features to support evolving regulations.

Person lab coat investigating a medical device

ProPharma: Your Organization’s Preferred Electronic Data Capture Partner

ProPharma's R&D Technology team understands the criticality of selecting the right CTMS and excels in aligning your companies’ needs with regulations and GxP system best practices. Our comprehensive approach and expert knowledge ensure that your organization is set up for long-term success. Our team has extensive experience in the following areas:

Service Category

How We Can Help

Strategy & Business Process Optimization

  • EDC System Selection
  • Roadmap Development

Clinical Research Solutions

  • Service Adverse Event (SAE) Reconciliation
  • Database Cleaning & Query Resolution
  • Medical Coding (MedDRA, WHO Drug)
  • Staff Augmentation

Implementation Support

  • Project Management
  • Configuration & API Integrations
  • Controlled Document Creation (SOPs, Work Instructions, and Job Aids)
  • User Administration & Training
  • Change Management

Validation

  • EDC Validation Coordination
  • User Acceptance Testing

Managed Services

  • System Administration
  • Release Management
  • System Optimization

EDC Study Build and Edit Check Programming

  • Case Report Form Design
  • EDC Study Build
  • Edit Check Programming
  • Protocol Amendments/Revisions
  • Clinical Coding
  • Reporting and Dashboarding

EDC System Support from ProPharma

If you are interested in implementing or optimizing your EDC system, ProPharma's R&D Technology team comprises experienced consultants who can advise your digital transformation. If you are interested in partnering with ProPharma on any of the services above, contact us via the form below. We look forward to working with you!

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