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Express EDC

Single Platform. Any Device. Enterprise Solution.

Why is the all-in-one, web-based Express 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, Express is the foundation of many leading research programs and is used on thousands of studies worldwide.

eSource Made Simple
Express 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 Trident IRT
Conveniently do Trident subject randomization, dosing and kit assignment within Express– 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, Express provides all of the essential tools — each tailored to the individual user. Express 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 Express.

Study Managers

  • Fast study builds
  • Instant access to clean, real-time data
  • Easy mid-study changes with one click — no system redeployment!
  • CDISC standard input and output
  • Custom workflows to maximize efficiency and productivity
  • Configurable status flags/tags that keep workflow moving
  • Proactive email notification about action items (status, linked and tagged forms, queries, SAEs, etc.)
  • See when forms are expected and which ones are late or missing, guiding CRA workflow to what's most important while eliminating unnecessary monitoring visits
  • Integrated IRT and ePRO capabilities

Site Users

  • An easy-to-use interface (all new in 2014!) for clean data entry
  • Full-power Trident randomization, dosing, and kit assignment
  • Easily do complex time and events for subject visits via nested folder structure

Operations Team

  • A scalable, cost-efficient platform that supports Phase I to post-marketing studies

Data Managers

  • 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

Management Team

  • Real-time data accessibility and visibility into study progress and site performance
  • Data review displays customized for personal or shared review

Site Monitors

  • Data accuracy right at the source, supporting targeted and centralized monitoring
  • Supports reduced Source Document Verification (rSDV)
  • Supports centralized monitoring

IT Group

  • Only one system to deploy — removes integration barriers!
  • Third-party integration with other eClinical systems

Entire Team

  • 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

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. Express 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.

Express EDC Resources

White Papers

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

Given the number of data sources that have to be integrated with your electronic data capture system (EDC), it's important to take flexibility into consideration when choosing an EDC. However, some EDCs make integrating with other systems easier than others.

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 E

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.

ADDITIONAL RESOURCES

Express EDC

Download Data Sheet

Full-Service Data Management & Enhanced Biometrics

Download Data Sheet

SAS Programming Services

Download Data Sheet

eHealth Patient Journey

Download Infographic

Pharmacyclics: First drug gets rolling, Express EDC utilized

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LEARN MORE OR SPEAK WITH OUR EXPERTS

CONTACT US
Leader in Clinical Trial
Management Solutions

Bioclinica is divided into three business segments so that we can provide expert service and multifaceted technologies. Our Medical Imaging and Biomarkers segment includes an Imaging Core Lab, a Cardiovascular Safety division, and a Biomarker Laboratory. Our eHealth segment comprises an eClinical Solutions Division along with Safety and Regulatory Solutions. Under the Global Clinical Research segment, we offer a network of research sites, patient recruitment, and a Post-Approval Research division.

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