eClinDirect, DSG’s web-based Clinical Trial Management System (CTMS), is a project management application that helps you to capture and share a wide variety of clinical trial project status information across multiple studies. eClinDirect gives you unparalleled control over your study.
Advanced reporting functionality provides easy access to metrics, workflow events, action items, documents collected and protocol deviations. Providing a detailed view of your entire study in real time, at all times.
The CTMS 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 application. Accessible anywhere in the world via an Internet connection, ClinDirect provides a centralized database for sharing clinical trial information. 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.
ClinDirect 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.
eClinDirect CTMS Features:
- For CROs, the ability to track studies across the Divisions of multiple Sponsors.
- Investigator database including status, categories, office locations, personnel, and credentials.
- Configurable categories allow the user to filter the online Investigator report, narrowing down search for potential sites.
- Configurable dashboard of key activities.
- Receive e-mail alerts of workflow events. Drill down directly to a monitoring visit form from the workflow alerts screen.
- Edit checks fire “Complete & Sign,” ensuring completeness of monitoring visit form questionnaires.
- User roles can be configured to have read only, read/write, or e-Signature authority.
- Once uploaded to the server, electronic documents can be retrieved by anyone with appropriate access authority.
- Extensive capture of protocol deviation information.
- Record adverse event findings relevant to visit monitoring procedures.
- Payments Module includes budget-versus-payment and time-phased reporting.
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Once entered into eClinDirect, CRA monitoring visit reports are available online, in real-time for all stakeholders with access. Role-based security provides various levels of access control.
eClinDirect 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.
eClinDirect 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.
Extensive information about protocol deviations is recorded from within the visit monitoring form. Additionally, violation classifications are configurable.
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.
eClinDirect 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.
Various payment categories and payees are configured and budget milestones defined. Payments are recorded against these budget milestones. A variety of budget vs. actual reports are available.
eClinDirect’s 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.