Solutions
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Electronic Data
Capture | EDC
Capture | EDC
eClinical tool for the collecting, validating, and enriching of clinical research data and patient registries
Developed for all organizations within the Life Science Industry
EDC is, together with the eClinical tools CTMS & ERMS, part of the ResearchManager research platform.
TRUSTED BY, AMONG OTHERS
Electronic data capture for all study types
Data Management
- No more paperwork. Collect and manage all clinical data safely and anonymously in the electronic case report form (eCRF).
- Suitable for all types of studies, such as; observational research, retrospective research and non-direct patient-related research (Biobank).
- Easily design studies with study templates. Save extra time by letting all of your questionnaires be implemented in the eCRF by our consultants.
- Shared library, to save, share, and reuse questionnaires.
- Document management to manage all patient related information in one spot.
RTSM
- Randomization Tool: Carry out a randomised control trial (RCT) to eliminate selection-bias.
- Use the Stratification tool to include or exclude participants from the study based on demographic characteristics.
- Trial Supply Management: Manage the entire medicine supply and issuance per participating centre with the built-in supply management.
- Monitor the medicine issuance to subjects and the safety with Smart Safety Reporting, like SAE’s, SUSAR’s, and SADE’s.
ePRO | PROMs | eCOA | Survey Tool
- ePro stands for electronic Patient reported outcomes, also known as PROMs, eCOA, or Survey Tool. Use this functionality as a questionnaire tool to send questionnaires to patients. This functionality is responsive, so that respondents can answer the questionnaires on any device (for example, smartphone, laptop, tablets, or computer).
- All results are automatically saved in the eCRF.
- Researchers can monitor the statuses and results by using study dashboards.
- All participating sites can easily participate in multicentre studies.
- Set up different roles and accompanying rights per participating site through Role Based Access Control.
- Easily plan visits, keep track of registrations, and manage the issuance of medicine per participating site through subject visit tracking.
- Link the EDC tool with financial management of the CTMS tool and manage all the budgets, compensations and invoicing per participating centre.
- Get all the needed study information in one glance with study dashboards and real time rapports.
- Through the built-in analytics tool results can be requested at question or subject level.
- Import and export data from and to Excel (.csv, xls), SPSS or other desired filetypes.
- Let the eCRF automatically generate subject numbers and link externally collected data through Component Mapping.
- Let the EDC easily communicate with applications through an API.
- Link EDC with SURFcontext, Single sign-on (SSO), and an EPD. Furthermore, exchange information with Financial and HR systems or stream data to the eCRF.
- Audit Trail
- Data validation on field level
- Anonymized patient details
- Smart Safety Reporting
- Role Based Access Control
Services, Support & Compliance
ResearchManager offers various services before- and during the use of the tools.
- Consultancy & Training
- Assistance when setting up studies
- Implementing questionnaires into the eCRF
- Data migrations
- Functional Management
- Double-blind Randomization
- Exchanging data with third-party software, through APIs
- Change Management
ResearchManager offers various support possibilities; even in different time zones;
- Telephone support
- Live chat
- Ticketing system
- Online manuals & video content
- Updates & releases notes
- Webinars & Community
At ResearchManager ensuring quality is our top priority. That is why our organization and datacentres live up to high quality standards.
Our organization
Our datacenters
- ISO 27001 certified
- NEN 7510 certified
- 21 CRF PART 11 compliant
- GCP & GDPR compliant
- Security pen tests documents available
- The eClinical tools EDC, CTMS & ERMS of ResearchManager are a SaaS (Software as a Service) solution.
- Secured and certified datacentres based in the Netherlands
- ISO 9001 certified
- ISO 14001 certified
- ISO 27001 certified
- NEN 7510 certified
- Secured connection through EV SSL certificate from Comodo
- Dedicated AES 256 encrypted backup server
Electronic Data
Capture | EDC
Capture | EDC
eClinical tool for the collecting, validating, and enriching of clinical research data and patient registries.
Industries
Our eClinical tools
What can we do for you?
We facilitate everyone in the life science sector that is involved with research. We do this with an online research platform consisting of the eClinical tools EDC, CTMS & ERMS. With this we offer researchers one central environment for all the information and services which enables them to share data with each other and to bring research to a higher level. Furthermore, we have expertise in the area of collecting, validating, and enriching data.
Our eClinical tools
Customer Reviews
What our clients say about ResearchManager
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