The Most Robust Tool
for Clinical Data Collection

✔ Cloud-based data management system

✔ Ideal for CROs, sponsors, academic institutions, and individual researchers

✔ 21 CFR Part 11 compliant

✔ SCDM Technology Innovation Award award winner

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.

   

How Clinical Studio Works

Build a Study

  • Design a study from the ground up, without any special programming skills
  • Create your study your way with highly configurable tools
  • Quickly create complete, customizable, and branded studies

Deploy a Compliant Study

  • Complete study deployment support with site document management, version control functionality, and a file management system
  • Manage study changes and adaptations with a complete version control system
  • Easily migrate subjects and participants to new study versions

Collect Data

  • Clinical Studio makes paperless data collection a streamlined, organized process
  • A fully integrated medical coding tool, csCoder, is also available with the Clinical Studio platform
  • Access the database and medical coding dictionaries from a mobile phone or tablet

Review Clinical Data

  • Track all data being entered, updated, or deleted with complete audit trails
  • A risked-based monitoring feature aids researchers in the identification, analysis, mitigation, or isolation of clinical research risks
  • Create, respond to, or close queries instantly with the Query Management System

Collaborate Effortlessly

  • Allows external systems to read/write to the Clinical Studio database via the available web API
  • Easily control user site access with a centralized site and user management platform
  • ePRO capabilities allow research professionals to send notifications, reminders, and questionnaires and collaborate on data effectively

Extract Clinical Data

  • Create highly granular and detailed reports using the Ad Hoc Report Builder
  • JReview can be fully integrated as a menu selection for extensive complex analysis or graphical representation
  • Extract data to industry standard formats including SAS, SPSS, ODM and Excel data sets
 

To see even more features and functionality, schedule a product demonstration today.

   

Testimonials

... having the freedom and power to instantly build studies that I know are regulatory compliant and be able to plan a budget around a published pricing schedule has really allowed our business to thrive ...

Eric Kaye

Sr. VP Clinical Operations & Data Management, AHS
.. I took a 30 minute orientation, which was excellent! I taught myself the rest, I can build any type of study imaginable, this product was way overdue …

VP of Clinical Operations, Biomedical Research Company
Clinical Studio brings to the table a complete, flexible, mobile and affordable platform that clients can utilize according to their study needs. Whether it is an investigational study, or post-market registry, Clinical Studio provides the tools needed to run a clean study efficiently!

Jerry Stinar

Chief Technology Officer, FUEL Studios
The user interface is simple, and easy to navigate. With the complete branding ability, Sponsors can project a personal touch to their site users.

Clinical Data Manager, Pharmaceutical Company