Clinical Studio EDC System

Clinical Studio is a comprehensive, award-winning Electronic Data Capture (EDC) system that provides researchers with a solution that streamlines the study build, data collection and management of clinical research, thus saving time and reducing costs.

From initial study creation to collection and analysis of data, Clinical Studio’s cloud-based data management system and mobile capabilities remove the typical hurdles of clinical research by allowing data entry, access, and analysis anywhere, anytime. With the Clinical Studio EDC system, researchers can capture data directly at the source, reducing the time and cost of data entry.

Designed with special attention to the FDA’s Part 11 Compliance requirements, the Clinical Studio system ensures research data is collected and organized in alignment with federal regulations and clinical data management best practices. The Clinical Studio system lets you spend less time on tedious regulatory tasks and more time with the research and data that advances medical knowledge.

In a nutshell, Clinical Studio allows for:

    • Configurable data collection forms
    • Configurable data collection schedule
    • Collection of data from disparate locations (web-based data input)
    • Integrity / logic checks on data (Conditional Actions)
    • Query system to work through data issues in conjunction with Conditional Actions
    • Configurable workflow for data approval and locking
    • Structured and real-time extraction of data
    • Role-based security to define access

Read more details about the features here.

Both evolved and mobile

As an EDC system, Clinical Studio was designed to support research professionals and organizations in the collection and analysis of clinical trial data.  Today, with the wide popularity of mobile devices and increasing importance surrounding patient centricity, the team behind Clinical Studio developed TrialKit to cater to the demands of modern clinical trials. TrialKit, a native iOS app, includes the same features and tools as Clinical Studio for each step in the clinical trial process, except it gives researchers the ability to conduct trials entirely on mobile devices.

From study build to data extraction and reporting, TrialKit gives clinical research professionals the greatest control over study design and how the data is collected and verified. As a cloud-based platform, integrating TrialKit into study workflow is as easy as downloading the app and logging in.  Studies can be conducted on Clinical Studio alone or in conjunction with TrialKit. Visit http://www.trialkit.com/ to learn more about how this app is revolutionizing clinical research.

How is it different than other eClinical/EDC products?

If you’re familiar with other eClinical/EDC products, then you may be rightfully asking yourself, “what makes Clinical Studio different?” There are several characteristics that distinguish Clinical Studio.

  1. Monthly fee. Unlimited users. Our industry-leading pricing is based on the number of studies, not the number of users. This allows for tremendous cost-savings for sponsors and researchers and business opportunity for CROs.
  2. True SaaS (Software as a Service) platform. You start the subscription when you are ready, after you have a chance to evaluate the system for free. You pay for as many studies as you need. Downgrade, upgrade, or cancel the subscription at any time. Export your data freely. You are in complete control from start to finish without commitment.
  3. Manage your own website host. A website host is the primary organizational unit in Clinical Studio. Think of it as an organization’s account. When you sign up for an account, the system creates a Website Host. Within your website host, add as many users as you want and create as many studies as your subscription allows.
  4. Regulatory compliance. Clinical Studio is capable of building and enforcing CFR 21 Part 11 compliant studies to meet FDA and applicable international regulations.
  5. Fully featured eClinical System. Clinical Studio offers an impressive array of functionality and capabilities. Not only will you save money, you will save time.
  6. Full service or self-service. You have the opportunity to fully build and manage your studies or utilize one of our certified partners. You could even do a combination, like outsource your study build and do your own data management. Check out our service offerings if you would like to outsource any part of your eClinical process.