Clinical Trial Management Software
- Platform for Clinical Trial Management
- Connected to our EDMS
- Synchronized with EDC and integrated with CDMS
- Fit for global regulated industries
- Cloud or on premise
The CTMS Challenge
Sponsors (such as pharmaceutical companies, biotechs) are looking to market their new drugs even faster than before.
This is the challenge of the CTMS for clinical research, to be more efficient in the monitoring and management of numerous clinical studies necessary to bring clinical research programs to a successful conclusion, while also ensuring compliance with the regulatory constraints and recommendations of the FDA.
Ennov CTMS offers both clinical trial monitoring and multi-study supervision. Visibility and decision support helps make you more effective.
Benefits of CTMS
- Integrated with CDMS
- Manage more studies and complexities
- Compliant with 21 CFR Part 11
- Optimized: on-site visits and off-site monitoring
- Compliance by respecting regulatory constraints
- Global: 24/7 availability for multiple site studies.
Manage the administrative, regulatory and financial information of your clinical trials, including changing the titles, descriptions and references of trials, promoters and associated centers, inclusions, competent authorities, CNIL, CPP, insurance, financial convention, chronology, actors and tests…
CTMS centralizes management of administrative, regulatory, and financial data for clinical trials with a single platform.
It includes the main SIGREC fields (including mandatory fields), and allows the transfer of general data and cumulative inclusions to the SIGREC server.
Master Monitoring Clinical Trials
Ennov CTMS allows CRAs to manage the end-to-end of clinical trials, from the prequalification of investigators to the administrative and financial closings of the centers. The data entered into the investigating centers are automatically available (through the native integration with Ennov CDMS).
All participants of the trial (such as the Sponsor, Monitor, Project Manager, CRA, CRO, Clinical Trial Manager, and Statistician) can access the application remotely according to their rights, allowing collaborative work on each study.
All in one accordance with your habits and procedure (declaration of EIGs, Contact, report of monitoring visits…), is easily adjustable within the tool.
Identify trends and differences between investigators, centers, and studies to make the right decisions.
CTMS offers complete support for the preparation of the monitoring visits and the drafting of the visit reports and follow-up to assist in the trials.
- Centralized: one place to house trial information
- Integrated with metadata or other clinical data management solutions (3rd party EDCs)
- Streamlined workflows of trial coordinators and investigators
- Effective with visibility and decision support
- Linked together with CDMS
- Management of Therapeutic Units (TU) and study materials
- Easy set up of studies
- Track study expedentures
- Entry follow-up
- Multiple classification plans
- Easy for CRAs and project managers
- Manage more studies and complexities with the same resources
- Drafting and remote electronic signatures of monitoring visits and reports
- Full web interface
Cloud-based or On Site
EDC – one of our Clinical Solutions
Why Choose Ennov ?
Hundreds of corporate customers trust Ennov
- 15 Years of experience in Clinical
- 150+ life science customers, many more in other industries
- Modern architecture and interface
- Application server for scalability
- You matter to us
- 98.5% of projects delivered on time and within budgets
- High and improving customer satisfaction
- Use of human resources: time spent on various steps
- Compare activities over similar products / period of time
We respect your freedom of choice
- Available as cloud or on premise.
- You can switch between options at any time.
- We make you autonomous
- Configuration requires no IT skills
- Improved security and optimized performance.
- Data is hosted locally for total flexibility
- Full range of pre-integrated clinical study tools.
- Based on our high end EDMS/BPMS platform.
Structuring AND intuitive
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