Collect clinical data during Pilot, Pivotal & PMS trials with ResearchManager EDC. This Electronic Data Capture contributes to the research & development for medical devices. Thanks to an extensive set of functionalities the high quality data is captured faster than ever before.
Link ResearchManager EDC with ResearchManager CTMS for a complete eClinical solution. This eClinical Trial Management System for medical devices manages and registers budgets, expenses, and compensations for all patient visits.
With Electronic Data Capture (EDC) you easily design and build your eCRF for pilot studies. Reuse study templates with shared libraries and collect patient data according to CRF Part 11, ICH E6 Good Clinical Practice (GCP) & GDPR guidelines.
Save extra time and let all your questionnaires be implemented in the eCRF by one of our consultants. After that the EDC environment is ready to collect and enrich clinical data during Pilot studies.
Electronic Data Capture | EDC, powered by ResearchManager
Capture clinical data during single or Multicentre pivotal studies. By using the EDC procedures can easily be planned and managed. Get a complete overview of all the budgets, expenses, and compensations by using Financial Management in the Clinical Trial Management System (CTMS).
By using the eClinical tools EDC & CTMS, MedTech are supported in efficiently collecting clinical data during the road to obtaining the CE-marking, and complying with MDR & IVDs regulation.
Clinical Trial Management System | CTMS, powered by ResearchManager
Safeguard the quality of medical devices during Post-Market Surveillance (PMS) & PMCF. During these registers ePRO can be use as Survey Tool. With this EDC sends questionnaires to respondents based on the sending schedule. Questionnaires can easily be filled in on a smartphone, tablet, laptop, or computer. The data is automatically sent to the eCRF.
Easily get insight in running studies and real-time data per participating site through study dashboards. With the built-in analytics tool it is possible to analyse the results on question level. For extensive analyses the data can be exported to for example, Excel and SPSS.
ResearchManager is official partner of Antive, CRO for Medtech organizations.
ELECTRONIC DATA CAPTURE
FOR THE research & development OF MEDICAL DEVICES
Data Management
- No more paperwork. Collect and manage all clinical data safely and anonymously in the electronic case report form (eCRF).
- Collect data during Pilot studies, Pivotal studies, and Post-Market Surveillance (PMS) studies.
- Supports in the efficient collection of clinical data on the way to CE marking, and compliance with Medical Device Regulation (MDR) & In Vitro Diagnostic (IVDs) regulations.
- Shared library, to save, share, and reuse questionnaires.
- Document management to manage all patient related information in one spot.
Randomization & Stratification
- 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.
- 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 THE research & development OF MEDICAL DEVICES
- 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.
Financial Management
- Manage budgets, expenses, and reimbursements.
- Link the CTMS tool with the EDC tool to plan visits and collect data per participating site.
- Generate all amendments & progress reports within CTMS, and let them be reviewed by a Medical Ethics Review Committee (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.
