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Single Platform. Any Device. Enterprise Solution.

Why is the all-in-one, web-based Bioclinica's 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.

Single Platform

eSource Made Simple
Bioclinica's 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 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 Bioclinica EDC in-house

 

Agile, Scalable, Full-Service Clinical Data Management.

Everyone knows clinical trials are growing more complex. Yet that doesn’t mean that you have to take on the increasing complexity of clinical data management (CDM). Free up valuable time for your team to focus on the important tasks requiring their expertise.  Don’t have an established data management ecosystem? We’ve done it all before: SOPs, automated listings, coding tools, dictionaries, macros, and more.

Simplify Data Management

Be confident that your data is efficiently and appropriately managed by our experienced data managers. We handle the details for you – from protocol review and specification documents to electronic case report form (eCRF) creation, page review, medical coding, through tables, listings, and figures (TLFs).

Maintain Control of Your Study

Whether it’s helping with one component of data management or providing end-to-end data management services, we work with you to determine how best to meet your needs. And, you always have full access to your data.

Accelerate Database Lock and Submissions

We pride ourselves on our agile services. Take advantage of start-up times for Bioclinica EDC and CDM of as little as eight weeks. Because we’re planning for study milestones, conducting QC checks and working with the Study Data Tabulation Model (SDTM) structure throughout the study, database lock occurs earlier, and we can deliver validated SDTM datasets within 48 hours after database lock.

Access One Point of Contact

Combine Bioclinica IRT, CTMS, EDC and CDM for true end-to-end support of your study and you won’t have to reach out to multiple vendors and project managers for project resolution. A Bioclinica project manager serves as your single point of contact for all software services.

Your project teams shouldn’t be mired in the minutiae of data management. Bioclinica CDM services will scale across your development portfolio and are delivered by experienced industry experts – at a fixed fee.

ENSURE HIGH-QUALITY DATA WITH BIOCLINICA’S COMPREHENSIVE CLINICAL DATA MANAGEMENT SERVICES

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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.

Bioclinica 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.

 

 

ADDITIONAL RESOURCES

CLINICAL DATA MANAGEMENT SERVICES

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OUTSOURCING OF HIGH-QUALITY, COMPREHENSIVE DATA MANAGEMENT SERVICES

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5 QUESTIONS TO ASK BEFORE CHOOSING YOUR EDC PROVIDER

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DATA-DRIVEN DECISION MANAGEMENT IN CLINICAL TRIALS

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

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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.

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