Collect clinical data during phase I, II, III, IV studies and patient registries with ResearchManager EDC. This Electronic Data Capture for Pharma & BioTech research contains a set of functionalities to capture high quality data faster than ever before.
Link ResearchManager EDC with ResearchManager CTMS for a complete eClinical solution. This eClinical Trial Management System for Pharma and BioTech research manages and registers budgets, expenses, and compensations for all patient visits.
With Electronic Data Capture (EDC) you easily design and build the eCRF for phase I & II (phase 1 and 2) studies. 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.
Save extra time and let all your questionnaires be implemented in to the eCRF by one of our consultants. Then the EDC environment is ready for collecting and enriching clinical data during BioTech & Pharma studies.
Electronic Data Capture | EDC, powered by ResearchManager
Capture clinical data during single or multicentre Phase III (phase 3) Pharma & BioTech studies. By using EDC operations can easily be planned and managed.
Via the Randomization Tool & Trial Supply Management (RTSM) researchers can carry out a randomized study with control groups (RCT). Furthermore, they can keep monitor the medicine supply and issuance per participating site.
RTSM, powered by ResearchManager
Safeguard and monitor the quality of medicine during phase IV (phase 4) studies & patient registries. With eCOA, a functionality within the EDC tool, researchers can send questionnaires to patients according to a sending schedule.
Get a complete overview of all budgets, expenses, and compensations through Financial Management in the Clinical Trial Management System (CTMS).
Clinical Trial Management System | CTMS, powered by ResearchManager
ELECTRONIC DATA CAPTURE
FOR pharma & biotech research
Data Management
- No more paperwork. Collect and manage all clinical data safely and anonymously in the electronic case report form (eCRF).
- Collect data during phase I, II, III, IV studies, drug studies, biomedical lab studies & patient registries.
- 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
- eCOA stands for electronic Clinical Outcome Assesment, also known as PROM’s, ePRO, 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 pharma & biotech research
- 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.
