We understand that you want a CRO that can do things faster, with greater accuracy and efficiency. That’s why we continue to enhance our TrialWare® suite of proprietary tools to ensure innovation.

Components of the Kendle TrialWare® technology family include: TrialBase®, our database management system; TriaLine®, our interactive voice response (IVR) patient randomization system; TrialView®, our validated medical imaging solution; TrialWatch™ our global project management system; TrialWeb®, our web-based clinical study collaborative tool and Trial4™, our late phase technology solution.

All project information is collected in and reported from TrialWatch™, which keeps all project team members and you aware of study progress via postings to TrialWeb®. In addition, this system also allows us to set and track a variety of study metrics in various areas of clinical development.

TrialBase® enables data to be processed faster by replacing forms with electronic images and utilizing standard database structures to automate workflow, conduct parallel processing and standardize procedures. Database development, data entry and queries are routinely available within a 72-hour turnaround.

TrialBase® key features

• Minimal manual CRF processing
• Multi-level edit checks
• Automated workflow
• Online review of data edit failures
• Computer-generated query forms
• Query tracking and reporting
• Automated coding
• Audit trail
• Clean database in record time
• 21 CFR Part 11 compliant

TriaLine® key features

• Multilingual randomization and trial supply management for multicenter clinical trials
• Real-time enrollment and visit information which allows for timely decision making
• Medication assignments for complex patient allocation schemes
• Just-in-time trial supply of both drugs and CRFs
• IVR rapid system development, testing and validation (4 weeks average) allows Kendle to meet deadlines that would prove impossible for other IVR systems
• Drug management
• Multilingual web “front end”
• 21 CFR Part 11 compliant

TrialView® key features

• Customized medical imaging solution, adaptable to any imaging device and format
• Optimizes clinical trial performance
• Complete validated solution for capturing digital image endpoints
• Fast and efficient image capture, publishing and analysis of endpoints
• Process-driven design ensures quality images, prevents image tampering
• Real-time access to images via TrialWeb®
• 21 CFR Part 11 compliant

TrialWatch™ key features

• Global, versatile, complete tracking of the study
• Monitors study progress across clinical groups in one system
• Tracks up-to-date study data entered from sources around the globe
• Links to other TrialWare® tools such as TriaLine®, TrialBase® and TrialWeb®
• Facilitates project/program communications with sponsor
• Full service studies provide an optimal platform for its use
• Replaces standard study workbook
• 21 CFR Part 11 compliant

TrialWeb® key features

• Internet-accessibility via kendle.com home page with user ID and password
• 128-bit SSL encryption (comparable to that used for electronic banking)
• Multiple security layers: SSL, Lotus Notes®/Domino™, database, document levels
• Project rooms for sharing of team documents, such as meeting minutes, action plans, team lists, protocols, site summaries, SOPs, etc. – removing the hassles of email, faxing and confirmation receipts
• Forum for team discussions
• Customizable features such as project links and tools
• Project search capabilities
• Online help, including user guide and frequently asked questions
• Optional photo image directory by site, patient, visit for real-time tracking of study progress
• Optional posting of confirmation and summary reports from TrialLine® IVR system
• 21 CFR Part 11 compliant

Trial4™ key features

Trial4™, our proprietary integrated study management system has been designed specifically for late phase studies. It utilizes core components of Kendle’s TrialWare® suite of technology tools, and allows us to capture clinical data, automate query handling and track study document and site status quickly and efficiently.

Trial4™ provides sites with the flexibility to mail or fax traditional paper CRFs or to enter the data directly onto a secure, web-based CRF. The technology enables automated entry of CRF data, leading to the cost-effective and timely collection of very large quantities of clinical trial data and nearly real-time report postings. It also automates site payments based on pre-defined study criteria that can be determined by the data retrieved. By integrating site management and data management into one simplified system we are able to offer you significant time and cost savings