Clinical Trial Technology

The workhorse of today's clinical trials

Get the blueprint

The electronic data capture platform (EDC) is undoubtedly the workhorse of decentralized clinical trials. That’s why the EDC figures prominently in our new eBook, Your Blueprint for Decentralized Clinical Trials.

To keep a decentralized clinical trial (DCT) running smoothly, it’s imperative that the streams of data from the ePRO, eCOA, medical devices, EHRs, third party labs, telemedicine services and more are available and actionable in real time. As a result, the EDC system needs to be able to orchestrate the complete data collection process in a precise and reliable manner. This foundational system is where all the data ends up, is reviewed, cleaned and prepared for analysis.

Frankly, the choice to license an EDC is eerily close to a no-brainer. That’s because every stakeholder benefits from the use of an EDC.

  • Sites. EDCs give sites an easy and intuitive way to provide accurate study data, auto-notify users with actions required, auto-manage study calendars, and apply electronic signatures.
  • Participants. EDCs give patients a frictionless experience, enabling them to provide data anytime, anywhere from their own device.
  • Sponsors. EDCs enable sponsors to stay up to date with study progress, maintain regulatory compliance, and save money.
  • Data Managers & Study Admins. EDCs enable data managers to build, test, and push studies in a collaborative manner while ensuring strict change control. They also provide a toolset for provisioning sites and users, resolving queries, and creating datasets.
  • Monitors. The EDC system needs to do the heavy lifting for monitors and direct their focus to the highest areas of risk. Hybrid trials require less source data verification (SDV), enabling monitors to target higher value activities.
  • Developers and Partners. The most effective EDC systems have an extensive, reliable, and well-documented web services API based on the industry CDISC standards, making it easy for developers and third parties to get the study data from their systems.

To help you choose the most effective EDC for your decentralized and virtual clinical trials, the experts at OpenClinica created a thorough capabilities list:

  • Integration. The ability to incorporate disparate data sources seamlessly and in real time, e.g., from EHRs, labs, devices, etc.
  • Adaptability. The EDC needs to be adaptable to different, unpredictable usage environments, and usable on any device, screen size, and browser (both by participants as well as study team members.
  • End-User Experience. High quality, end-user experience that requires little to no training, performs real-time edit checks, calculations, dynamic logic, and automatic saving of data; supports collaboration; and allows different teams in charge of different aspects of the trial to be able to work together asynchronously.
  • Change Management. Robust change management to ensure data integrity across changes and a smooth user experience.
  • Flexibility. Flexibility to adapt to changing virtualization, the ability to launch a study with certain parts virtualized and change this as time goes by.
  • Flexible Notifications and Messaging. With more parties to coordinate, an EDC needs to be smart about prompting users about what they need to do and when.
  • Unfettered Analytics. The increased number of digital moving parts in a virtualized study produce data that can be used to enhance the study itself. This data can measure compliance rates, look for bottlenecks and breakdowns in the process, and identify unintended consequences before they become real problems.
  • Configuration Ease. Can the team be self-sufficient in building out their hybrid trial? Can they easily make changes and iterate quickly? How easily can the team take a change from design, to text, and finally to production?
  • Targeted Data Review and Verification. As more of a study becomes eSource, there is less data to review and verify. Thus, the ability to granularly define what needs to be reviewed can help monitors save time.
  • Incorporation of Point Solutions. An effective EDC platform needs to be able to play well with other pieces of technology via a robust web services API.
  • Remote Data Monitoring. Access to data within the EDC so that monitors can ensure source data follows ALCOA principles (attributable, legible, contemporaneous, original and accurate).

To learn more about OpenClinica Unite™, our award-winning EHR to EDC integration technology that automates source data acquisition from EHRs and EMRs to clinical trial research databases (EDCs) and case report forms (eCRFs) at scale, visit:

To download our complete decentralized clinical trials blueprint, click here.

Your browser is out-of-date!

Update your browser to view this website correctly. Update my browser now