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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

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.

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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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

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.

Resources

White Papers

Because a key step towards database lock is obtaining clean data for all patients, the ability to verify that data is clean early accelerates the ability to lock the clinical database. This ultimately shortens the overall study timeline while ensuring the quality of your data.

The promise of electronic data capture to improve the speed and quality of clinical trials is too great to be ignored. These eight "secrets to EDC success" will help you understand how to fulfill that promise and gain the full advantage of clinical EDC.

Blogs

Ever since the US FDA introduced Meaningful Use requirements calling for medical practices to begin using EHR systems, the race was on to find a way to pull the data from EHR systems into the EDC systems electronically.  Many options have been tried − most focused on accessing the data from the EHR in the native HL7 format.  While this solution works, it's not easy to do. One of the stumbling blocks is the inability of site personnel to access this type of data from their EHR.

At BioClinica's 2015 Global User Conference, I had the pleasure of leading an expert panel discussion on the future of data management. I would like to share some highlights from my perspective. Panel participants were Daun Bahr, senior director data management Orexigen; Queennette Santiago, head of data management Ultragenyx; Clara Plascencia, associate director of clinical data management Pharmacyclics; and Ann Seibel, clinical data manager BioClinica.

In my R&D role at Endo Pharmaceuticals, I have seen the lines between operations and clinical data functions becoming more and more blurred.

ADDITIONAL RESOURCES

Express EDC

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Full-Service Data Management & Enhanced Biometrics

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CLEAN PATIENT OPTICS

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SAS Programming Services

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eHealth Patient Journey

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Accelerate Your Database Lock with Clean Patient Optics

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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.

Great advice from our Dir. Cardiovascular Imaging on how to achieve top quality imaging acquisitions & assessments… https://t.co/P57970FrOf
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RT @CenterWatch: Examining the difference between #patient engagement & patient recruitment. Read more in #CWPulse by @AshleyTointon, https…
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RT @RAPSorg: What New @FDAcdrhIndustry Guidance is Coming in FY 2018: Alternative 510(k) Pathway and More | #Regulatory Recon https://t.co/…
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Congressman Meehan and Bioclinica CEO John Hubbard at recent visit to Bioclinica's Audubon offices