eCaseLink CTMS -Clinical Trial Management System
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eCaseLink - CTMS Clinical Trial Management System
Conveniently capture clinical trial status information
eCaseLink CTMS, is a powerful clinical trial web-based software application that is specifically designed for collecting and distributing electronically captured clinical trial status information quickly throughout multiple studies.
Real-time, real-site, advanced reporting
CTMS gives you unparalleled control over your study with advanced reporting functionality that provides easy access to metrics, workflow events, action items, documents collected and protocol deviations. CTMS delivers simple configuration, role-based security instills levels of access control including read-only, read-write, and workflow e-signature authority.
Accessible clinical data anyplace-anytime
Tracking progress at Investigator sites via paper visit monitoring trip reports is time consuming and delays access to critical status information about how the study is proceeding. DSG offers a web-based CTMS application that provides a centralized database for sharing secure clinical trial information such as the sponsor name, protocol name, investigators, and CRA monitoring visit reports, in real-time. Our role-based security provides various levels of access control including e-Signature that facilitates the electronic workflow of the visit monitoring forms.
DSG’s CTMS features:
- For CROs, the ability to track studies across the divisions of multiple sponsors
- Payments module includes budget-versus-payment and time-phased reporting
- Configurable dashboard of key activities
- Project and Site initiation milestone tracking reports
- A comprehensive Investigator database including status, categories, office locations, personnel, and credentials
- E-mail status alerts of workflow events directly to a monitoring visit form a workflow alerts screen
- Extensive capture of protocol deviation information
- Customizable role-based security
Additional features:
Site Payment Module – Calculates and reports what a clinical trial study Site has earned, based on participant data and actions recorded by Site personnel into EDC using predefined rules and triggers.
The benefits of eCaseLink CTMS:
Real-Time, Online Access to Information
Once entered into eCaseLink, monitoring visits reports are available online, in real-time for all stakeholders with access. Role-based security provided carious levels of access control.
Flexible CTMS, Easy Configuration
The CTMS configuration process begins with a determination of desired access control levels and the electronic workflow of the monitoring visit reports. Next, online monitoring visit report forms are customized to the needs of the particular sponsor or study.
Online Visit Monitoring Forms Workflow
eCaseLink validates that CRAs completed the monitoring form questionnaires, and supplied comments for questions with negative answers. All forms are routed via electronic workflow, using an e-signature design. E-mail notifications are available and all actions write to an Audit Trail.
Document Management
Paper documents collected at the sites are identified and electronic documents, if available, are uploaded into a repository. The extensive meta-data stored with the document is used as filter criteria when running the various document reports. Document categories and types are configurable, and the collection status of essential regulatory documents is tracked.
Reporting Functions
CTMS delivers real-time standard and customized reports provide easy access to metrics, workflow events, action items, documents collected, protocol deviations, and adverse events, summarizing the details needed to ensure the steady progress of any clinical trial.
Investigator Information
eCaseLink CTMS stores investigator and other stakeholder contact information, status, and credentials. Updated contact information is immediately available online. Additionally, investigator site information pre-populates in forms, reducing data entry.