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Unique study and data management tools
We understand 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:
TrialWatch® – our global clinical trial management system
- 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
- Facilitates project/program communications with sponsor
- Full service studies provide an optimal platform for its use
- Replaces standard study workbook
- Links to other TrialWare® tools for consistent project reporting
- 21 CFR Part 11 compliant
Argus Safety™ – our comprehensive adverse event management system
- Provides tracking, compiling, coding and reporting of adverse event information in accordance with client and regulatory requirements
- Ability for users to track patient history, lab tests, medications, correspondence, images and source documents
- Supports clinical trial, post marketing surveillance, literature and spontaneous cases
- Minimal manual CRF processing
TriaLine® – our interactive voice response (IVRS) patient randomization system
- 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
- IVRS rapid system development, testing and validation allows Kendle to meet deadlines that would prove impossible for other IVR systems
- Drug management
- Multilingual web “front end”
- Links to other TrialWare® tools for consistent project reporting
- 21 CFR Part 11 compliant
Kendle Connect – our participant access and retention system
- Connects potential subjects to sites via web or IVRS
- Encourages and tracks investigator referrals
- Metrics to assess all recruitment activities
- Web-based recruitment planning tool, based on site specific recruitment plans and projections
- E-platform for monthly site/CRA recruitment evaluation
- Real-time recruitment metrics, starting with the site’s pre-screening activities
- Data feed into a visible recruitment dashboard for analysis and planning at site, country, region, study and program levels
- Investigator access to real-time recruitment metrics
- Multilingual web and IVRS interfaces
- Links to other TrialWare® tools for consistent project reporting
TrialEAS® – our Web-based electronic alternative to paper-based adjudication of clinical endpoints
- Adjudicator access to all documents, scans and images wherever and whenever needed
- Reduced number of face-to-face committee meetings
- Allocation of events via several randomization protocols
- Multiple specialist endpoint committees within a study
- Adjudication of events on an ongoing basis
- Shortened timeframe for endpoint assessment
- Over-recruitment risk minimized through more efficient endpoint adjudication
- Transfer of adjudication to the clinical database on a regular basis, allowing ongoing medical review
- Document translation to language of choice
- Reduced or eliminated courier cost
- Links to other TrialWare® tools for consistent project reporting
- 21 CFR Part 11 compliant
TrialTMS® – our enterprise-level contact center solution for call management and automated workflow routing
- Enterprise-level contact center deployed globally in three Kendle offices
- Web-based task and call management system
- Integrated call delivery (Cisco Unified Contact Center Enterprise), task management, and call recording (Q4 2009)
- Global library of call flows to assist agent in answering telephone calls
- Ability to create custom call flows for each study/registry
- Links to other TrialWare® tools for consistent project reporting
- 21 CFR Part 11 compliant
eDocs – our Web-based regulatory document collection and collaboration system
- Web-base electronic regulatory document collection and collaboration system
- Automatic delivery of regulatory documents, based on site status, geography or timing
- Automatic pre-population of critical fields within distributed documents
- Supports electronic document signatures for fully electronic document maintenance and management
- Automatically distribute and track site response of safety alerts
- Links to other TrialWare® tools for consistent project reporting
- 21 CFR Part 11 compliant
TrialMD® – our global investigator feasibility and information management system
- Global investigator database with over 83,000 investigator profiles
- Centralized communication tool for coordinating investigator contact
- Investigator profiles designed to capture and leverage key physician interest and site capabilities.
- Sophisticated “Advanced Find” feature allows the development of protocol specific custom queries to identify strong potential sites.
- Includes key Site Startup, Patient recruitment, Data Management and Protocol Compliance metric.
- Self service investigator access ensures demographic accuracy
- Links to other TrialWare® tools for consistent project reporting
- 21 CFR Part 11 Compliant
TrialWeb® – our Web-based communications and information sharing tool
- 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 e-mail, 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
- Links to other TrialWare® tools for consistent project reporting
- 21 CFR Part 11 compliant
