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Electronic Data Capture (EDC)

Single Platform. Any Device. Enterprise Solution.

Why is the all-in-one, web-based Bioclinica Electronic Data Capture (EDC) used by Sponsors and CROs to build studies and capture data for thousands of clinical studies worldwide?

Summing it up: You get more. Do more. See deeper into your studies and manage study data, not just capture it — all within a single, powerful solution that puts everything at your fingertips. Ideal for any clinical trial regardless of size, phase or complexity, Bioclinica provides the foundation of many leading research programs and is used on thousands of studies worldwide.

eSource Made Simple
Bioclinica EDC equips study teams with easy-to-use tools for quick and efficient data collection right at the source on any device or desktop. A built-in survey tool makes it convenient for subjects to enter required data between visits.

Integrated Bioclinica IRT
Conveniently do IRTsubject randomization, dosing and kit assignment within Bioclinica EDC– without compromising power or performance.

Value for All Stakeholders
Advanced analytics and on-demand reporting capabilities enable managers to see study progress as it is happening. Operational and research decisions are continuously informed by standard and customized reports that can be run at any time.

So whether you are a data manager, site investigator, monitor, or member of the operations group, Bioclinica provides all of the essential tools — each tailored to the individual user. Bioclinica EDC makes all aspects of the clinical trial process easier, faster, and more efficient — with clean data right at the point of entry. And integration, security, and high scalability earn high marks with IT teams.

Here's what various users say they value most in the feature-packed EDC.

  • Fast study builds
  • Instant access to clean, real-time data
  • Easy mid-study changes with one click — no system redeployment!  
  • CDISC ODM output and input
  • Custom workflows that maximize efficiency and productivity
  • Configurable status flags/tags that keep workflow moving
  • Ability to code adverse events and concomitant medications via auto-coding in a fraction of the time or manually
  • Real-time data accessibility and visibility into study progress and site performance
  • Data review displays customized for personal or shared review
  • Data accuracy right at the source, supporting targeted and centralized monitoring
  • Supports reduced Source Document Verification (rSDV)
  • Supports centralized monitoring
  • Only one system to deploy — removes integration barriers!
  • Third-party integration with other eClinical systems
  • All of the needed tools in one convenient system!
  • 24-hour live support
  • EDCplus Technology Transfer option lets you take control of your studies by bringing Express in-house

Unified Medical Imaging, EDC & IRT

When medical imaging, electronic data collection and recruitment and randomization are managed separately, clinical trials are burdened by duplicate data entry, excessive time resolving enquiries and manual reconciliation between systems. Bioclinica’s best-in-class integration of medical imaging, EDC and IRT bridges critical aspects in the clinical trial to enable the collection, visibility and management of Bioclinica Medical Imaging, Bioclinica EDC and Bioclinica IRT data and to achieve a harmonious workflow – through a single dashboard.

EDC ↔ Imaging
Accelerate your clinical trial with quality data and benefit from:

  • Proactive visit-based requests for missing images
  • No delays with monthly logs
  • No manual reviews/reconciliation and updates
  • No data management loads, edit checks, and data diagnostics
  • Imaging visit dates that facilitate site communications for outstanding data
  • Clear view of subject status and subsequent imaging visits

EDC ↔ IRT
Streamline multiple critical processes across the trial continuum and benefit from:

  • Reduced data entry cycle times
  • No need to develop, test and support dedicated IRT-EDC integrations
  • Common site interface to concurrently capture subject data, randomize subjects and dispense drugs
  • Real-time notification, eliminating delays for monthly screening and enrollment lists
  • Real-time access to the complete IRT-EDC dataset
  • No IRT-EDC data reconciliation

Unified Medical Imaging, EDC & IRT

Bioclinica's integration of these systems unifies key processes, creating opportunities to improve the experience of patients and sites alike.

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Power. Performance. Scalability.

Built for the demands of the most complex clinical studies, Bioclinica's best-in-class EDC makes no compromise on tools, capability, or performance. Bioclinica provides world-class hosting for high-speed access to study data within a fully compliant environment. The robust system meets all regulatory guidelines and conventions, including 21 CFR Part 11 and ICH-GCP.

Express EDC brings speed, quality, and efficiency to clinical study data. Managers can get on-demand study data in SAS and CDISC ODM formats with self-serve exports. Automatic alerts for anything ranging from SAEs to signature removals ensures timely study team response to both clinical and operational issues. Embedded data management and review tools used for query workflows, record linking, and bookmarking, tagging, and custom review statuses facilitate sponsor or CRO data review and process management. All this with an easy-to-use interface earns high marks from site users responsible for entry of clean data.

Accelerate Database Lock with Clean Patient Optics

Clean Patient Optics is a first-of-its kind solution that helps focus data cleaning, allowing your study team to meet or beat the database lock goal by days or even weeks. It provides uninterrupted visibility into patient data status at the study, site and patient level, empowering study teams to optimally focus the data cleaning process and remove obstacles that can create costly delays.

This innovative solution - readily implemented as a companion product to Bioclinica's EDC and Data Management services - serves as an early warning system, signaling if a vendor is behind on making updates, or if a site is slow in reporting SAE information to the pharmacovigilance team. Study teams can uncover patterns and observations about the status of patient data external to the EDC system, such as ECG, Central Safety Lab and other important data requiring reconciliation, helping avoid surprises at the end of a study.

With Clean Patient Optics you can achieve:

  • Better and faster identification of specific bottlenecks to take action quicker
  • Improved data cleaning resource allocation
  • Decreased time to database lock ─ and with fewer surprises
  • Lower costs through improved efficiencies

Accelerate Database Lock with Clean Patient Optics

Using the powerful data visualization tools in Clean Patient Optics, study teams can uncover patterns about the status of patient data external to the EDC system for early identification of potential study problems.

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ADDITIONAL RESOURCES

CLINICAL DATA MANAGEMENT SERVICES

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EDC Overview Sheet

Download Overview Sheet

Full-Service Data Management & Enhanced Biometrics

Download Overview Sheet

CLEAN PATIENT OPTICS

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UNIFIED MEDICAL IMAGING, EDC & IRT

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SAS Programming Services

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eHealth Patient Journey

Download Infographic

Accelerate Your Database Lock with Clean Patient Optics

Download White Paper

Top 10 Sponsor Improves Trial Data Quality through Bioclinica’s EDC eSource Solution

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Pharmacyclics: First drug gets rolling, Express EDC utilized

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Leader in Clinical Trial
Management Solutions

Successful clinical trials require the ability to see key details and uncover hidden insights. Bioclinica utilizes science and technology to bring clarity to clinical trials, helping companies to develop new life-improving therapies more efficiently and safely.

ICYMI: Take a look at Bioclinica Clinical Adjudication that caught the judges' eye in the recent Scrip Awards. It's… https://t.co/gPk4aLmTuA
Bioclinica (2 weeks ago)
Still time to catch up with Aina Lihn, Kathleen Kane, Anette Vierning and other Bioclinica folks at #PCTRIALS https://t.co/E3qxdjqTV5
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Awesome day 2 at #PCTRIALS in Barcelona! Great to connect w new & long-time partners & #lifescience clients! https://t.co/ElM3VPCoSk
Bioclinica (3 weeks ago)
Great talk by @bioclinica's CIO & EVP Technology Gavin Nichol at #PCTRIALS 2018 on #FDA recent guidance on EHR EDC… https://t.co/geIjGIFL06
Bioclinica (3 weeks ago)
Great talk by @bioclinica's CIO & EVP Technology Gavin Nichols at #PCTRIALS 2018 on #FDA recent guidance on EHR EDC… https://t.co/agqP32q09W
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Ask us about technology-enabled clinical development powered by science! Hear our CIO in a day 2 talk. See… https://t.co/iZyF8ixV79
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