diCELLa CTMS
The CTMS module is capable of efficiently handling multiple projects. Even if the eCRF of diCELLa is not used, the system provides advanced APIs for seamless integration and data transfer to CTMS. Additionally, depending on the team's organizational structure, distinct authorizations and access to diverse projects can be extracted for a single user.
CTMS is the main module of the diCELLa Unlimited platform responsible for data integration and support in clinical tral management
CTMS is the main module of the diCELLa Unlimited platform responsible for data integration and support in clinical tral management
diCELLa CTMS
Entities key features:
- Management of entities related to the clinical trial.
- The possibility of creating different categories of entities.
- The ability to assign a subcontractor to various projects.
- Contact management.
- Knowledge management in the organization.
- Improving contact with entities.
Patiens key features:
- Patient lists from all sites in the clinical trial.
- Patient visit analysis.
- Analysis of the completion status in the eCRF.
- Recruitment progress statistics.
- Patient distribution e.g. gender, age.
- AE/SAE for the patient.
- Concomitant medication.
- IWRS - dispensed IMP.
- Additional visits.
Sites key features:
- List of active and inactive centers.
- Facility calendar.
- Events in the site, noting the main events of the eCRF.
- List of patients of the center.
- AE/SAE list.
- Team list at the site.
- Ability to add a monitoring visit report.
- Management of entities related to the clinical trial.
- The possibility of creating different categories of entities.
- The ability to assign a subcontractor to various projects.
- Contact management.
- Knowledge management in the organization.
- Improving contact with entities.
Patiens key features:
- Patient lists from all sites in the clinical trial.
- Patient visit analysis.
- Analysis of the completion status in the eCRF.
- Recruitment progress statistics.
- Patient distribution e.g. gender, age.
- AE/SAE for the patient.
- Concomitant medication.
- IWRS - dispensed IMP.
- Additional visits.
Sites key features:
- List of active and inactive centers.
- Facility calendar.
- Events in the site, noting the main events of the eCRF.
- List of patients of the center.
- AE/SAE list.
- Team list at the site.
- Ability to add a monitoring visit report.
Projects key features:
- All Sponsor projects in one platform.
- The ability to assign projects to specific managers.
- Recent events in your studies.
- 100% integration with eCRF.
- Integration via API, possible other ways.
- Recent events notifications.
Users key features:
- Monitoring user logs.
- Analysis of work in the system.
- Monitoring of displayed patients.
- Analysis of completed fields.
- Query response analysis.
- Login history.
- The ability to attach files.
Queries and Monitoring Activities key features:
- Queries list.
- Analysis of the queries in the time period.
- Analysis queries vs. monitor.
- Histograms queries vs. visits and field in the eCRF.
- Number of successful logins per user.
- Automatic CRA report.
- Number of successful logins per user.
- Number of open queries per user.
- Number of SDV fields per user.
- Number of visited patients.
- All Sponsor projects in one platform.
- The ability to assign projects to specific managers.
- Recent events in your studies.
- 100% integration with eCRF.
- Integration via API, possible other ways.
- Recent events notifications.
Users key features:
- Monitoring user logs.
- Analysis of work in the system.
- Monitoring of displayed patients.
- Analysis of completed fields.
- Query response analysis.
- Login history.
- The ability to attach files.
Queries and Monitoring Activities key features:
- Queries list.
- Analysis of the queries in the time period.
- Analysis queries vs. monitor.
- Histograms queries vs. visits and field in the eCRF.
- Number of successful logins per user.
- Automatic CRA report.
- Number of successful logins per user.
- Number of open queries per user.
- Number of SDV fields per user.
- Number of visited patients.
- Study documentation management.
- SOP list.
- List of contracts.
- eTMF/eISF integration with eCRF.
- eTMF/eISF the ability to set an expiration date and notify about the approaching expiration date.
- Ability to update documentation from CTMS to eCRF.
- SOP development with audit trail module.
- Agreement development with audit trail module.
