eCaseLink CTMS

Gain control of your studies with DSG's Clinical Trial Management System (CTMS)

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.

eCaseLink 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.

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The Clinical Trial Management Challenge

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 Clinical Trial Management System CTMS application. Accessible anywhere in the world via an Internet connection, eCaseLink CTMS provides a centralized database for sharing secure clinical trial information. The information about the sponsor, protocol, and investigators, and CRA monitoring visit reports are also available online, in real-time. Role-based security provides various levels of access control. An e-Signature function facilitates the electronic workflow of the visit monitoring forms.

The CTMS Solution

Investigator visit monitoring reports should be entered into a relational database, making their content available to any user anywhere in the world with an Internet connection and the proper security credentials. Reports can be generated in real-time, showing the planned-versus-actual status of monitoring activities and exposing protocol deviation and adverse event reporting issues in a timely manner.

DSG’s unique approach validates that the online visit monitoring form questionnaire is filled out completely; that comments exist for questions with negative answers. The online form is then routed via electronic workflow using an e-Signature design. E-mail notifications are available, and all actions write to an Audit Trail.

DSG’s CTMS solution makes the content of the monitoring visit forms available online, in real-time for review by members of the project team. Advanced reporting functions provide easy access to metrics, workflow events, action items, documents collected, and protocol deviations.

DSG’s CTMS is configurable. The configuration process begins with a discussion of the desired access control levels and electronic workflow of the monitoring visit reports. The online monitoring visit report form questionnaires are customized to the needs of the particular sponsor/study. The Investigator information is then loaded into the product’s relational database and users are defined to the system. Customized reporting is available.

eCaseLink 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 / Site initiation milestone tracking and reports
  • The comprehensive Investigator database includes status, categories, office locations, personnel, and credentials
  • Receive e-mail status alerts of workflow events. Drill down directly to a monitoring visit form from the workflow alerts screen
  • Extensive capture of protocol deviation information
  • Customizable role-based security

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

eCaseLink CTMS is easily configurable. The 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. Online forms are routed via electronic workflow, using an e-signature design. E-mail notifications are available and all actions write to an Audit Trail.

Protocol Deviations

Extensive information about protocol deviations is recorded from within the visit monitoring form. Additionally, violation classifications are configurable.

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.

Investigator Contact 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.

Payments

Payment options are established with defined budget milestones. A variety of budget vs. actual reports are available

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.