Collect, validate, and save unlimited amounts of data in one central place with ResearchManager EDC. With the Electronic Data Capture tool colleges, universities, Medical Centers, and research institutions reach high efficiency and are guaranteed to get high quality data.
Link ResearchManager EDC with ResearchManager CTMS for a complete eClinical solution. This Clinical Trial Management System for academic institutions, gives an overview of all studies. Furthermore, all the necessary information is directly available for inspections and year reports.
Exchange all the paperwork for ResearchManager EDC. Via Electronic Data Capture with built-in eCRF, you can design, build, and save questionnaires faster than ever. Reuse study templates with shared libraries and collect all patient data according to the 21 CFR Part 11, ICH E6 Good Clinical Practice (GCP) & GDPR guidelines.
Easily create new accounts and roles within the EDC tool. Determine the rights per role via Role Based Access Control.
Electronic Data Capture | EDC, powered by ResearchManager
Use ePRO as Survey Tool, to safely, quickly, and anonymously collect data. Use this functionality a questionnaire tool to send questionnaires to respondents.
To increase the reliability of research, the stratification tool can be used to include or exclude test patients from the database. Furthermore, control groups can be created through the Randomization Tool.
Electronic Data Capture | EDC, powered by ResearchManager
With ResearchManager CTMS, all researchers can streamline study requests and manage portfolios. Generate your own workflow to receive approvals internally.
Send the study protocol of studies related to Medical Research Involving Human Subjects to a Medical Ethics Review Committee (MERC) for a review.
Clinical Trial Management System | CTMS, powered by ResearchManager
ELECTRONIC DATA CAPTURE
FOR ACADEMIC INSTITUTES
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. Ideal for PhD studies. Save extra time by having all questionnaires 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
Capture | EDC
Clinical Trial Management system
FOR academic INSTITUTES
Financial Management
- Manage budgets, expenses, and reimbursements.
- Link the CTMS tool with the EDC tool to plan visits and collect data per participating site.
- Get insight in all statuses from ongoing studies through study dashboards.
- Through Management dashboards all the information needed for inspections and year reports are directly available.
- Generate study requests, amendments & progress reports, within CTMS and let them be reviewed by a Medical Ethics Review Committees (MERCs).
- With CTMS participating sites can take the necessary actions per step via their own workflow.
- By using Communication Management there can easily be communicated with involved roles within all participating sites in CTMS.
- Let the CTMS easily communicate with applications, through an API.
- Link with SURFcontext, Single sign-on (SSO), and an EPD. Additionally, exchange information with Financial and HR systems.
- Audit Trail
- Anonymized patient details
- Smart Safety Reporting
- Role Based Access Control
Management System | CTMS
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
Safety is our top priority. Our organization and data centres meet high quality standards.
