About Clinical Trial Management System
Secure, compliant and prepared for the future
Fast Study startup
- Workflow Management: CTMS recognizes which process steps and documentation belong to the selected study type (e.g. Screening Trial, Pilot study, Case Control study).
- Site Startup: Easily add sites/departments. CTMS automatically sends notifications when an action is required.
- Communication Management: Communicate easily in CTMS with all roles within involved sites/departments.
- Role Based Access Control different roles and rights can be set up per participating site/department.
Contract & Document Management (eTMF/ISF)
- Built-in templates & Reporting Engine: Generate study-required documentation and reports immediately in CTMS.
- ResearchManager eSign: Clinical research-related documents can be digitally signed securely (e.g. FDA 1572s, subject informed consent forms (ICFs) and e-Delegation logs)
- EC submission: Ethics Committees/IRBs can be accessed to review the protocols.
Clinical Subject Management
- ResearchManager eConsent: participants can be enrolled during on-site, hybrid or decentralized trials.
- Plan visits, keep track of registrations, and manage the issuance of medicine.
- ResearchManager EDC: sites are able to collect and manage all clinical data safely and anonymously in the electronic case report form (eCRF).
Track and manage the entire study portfolio
Real-Time Dashboards
- Study dashboards: Get insight in all statuses from ongoing studies (e.g. study types, duration, activities).
- Management dashboards: all the information required during inspections and yearly reports are directly available.
- Planning and Milestones: Set deadlines for certain study statuses and monitor processing times.
Financial Management
- Manage budgets, expenses, and reimbursements per visit/procedure.
- Link the CTMS tool with the EDC tool to plan visits and collect data per participating site.
Amendments & Reports
- Amendments & progress reports: Easy generation and internal or external review by an Ethics Comittee/IRB.
CTMS is part of the DCT platform
- Combine CTMS with EDC to collect data during on-site/Hybrid trials.
- Combine with eConsent and let participants screen and enroll remotely.
- Combine with ePRO to collect digital patient data during e.g. Hybrid or Decentralized Clinical Trials (DCT).
- Add the RTSM tool for trials that require Randomization, Stratification and Inventory Management.
Application Programming Interface (API)
- 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.
Good Clinical Practice (GCP)
- Audit Trail
- Anonymized patient details
- Smart Safety Reporting
- Role Based Access Control
Pricing
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Customer Reviews
Curious how our users rate ResearchManager? Take a look!
GOOD Based on 52 reviews
Neeraj P.
December 22, 2022.
Overall Good
Overall: Good Experience with lot of learning Pros: Designing and data entry is faster than other edc Cons: Have some issue with the site adding in the serial number.
Gabriella M.
December 19, 2022.
Great Product
Pros: I work for an orthopedic practice that collaborates with different medical device companies. Previously our work was paper-based but with RM we have been able to create and collect data in an efficient way. This platform is very user-friendly, with real-time data capturing and meets all the Good Clinical Practice and confidentiality criteria required in our practice. Cons: There is no real-time troubleshooting option available. If the issues issnt addressed in the FAQ an email needs to be sent and in most of the cases the response is in dutch.
Malgorzata K.
December 17, 2022.
It’s a good program, easy to use. I wish the technical support department was more responsive.
Overall: It’s a good program, easy to use. I wish the technical support department was more responsive. Pros: that you can easily edit it yourself, I like that as an administrator I can have several studies connected Cons: sometimes the system is not intuitive and you have to look for some tabs
pradeep kumar n.
December 16, 2022.
overall outstandin application.
Overall: there is no problem while using research manager. Pros: how the way research manager working on data capturing that is very nice. easily assess. Cons: capturing all the data quickly. overall very good application
Nagma k.
December 9, 2022.
Easy to use
Pros: Efficient and Fast data save automatically. Cons: Overall good but for finding all patient data list we need to go to home task.
Xaviera X.
December 9, 2022.
Mostly great
Overall: I am mostly pleased Pros: It’s mostly very easy to use. I have never had any seriously negative experiences with the software. Cons: Sometimes not always the most intuitive.
Jonne P.
October 4, 2022.
ResearchManager bij een klinische trial
Pros: gebruiksvriendelijk handige tools om eigen database te maken overzichtelijk dashboard uitgebreide opties tav design eigen database strakke lay-out Cons: geen minpunten ten aanzien van de studies waarvoor ik het gebruikt heb
Floris d.
September 5, 2022.
Maakt indienen makkelijk
Overall: Snel en makkelijk in gebruik. Pros: Snel indienen bij de METC, duidelijk overzicht Cons: Tot op heden geen. De software werkt prettig.
Martin G.
August 26, 2022.
Gebruiksvriendelijke database voor multicenter studie
Overall: Zonder uitzondering snelle beantwoorden van vragen. Pros: Gebruiksvriendelijk programma. Het bouwen van de database kan men zichzelf gemakkelijk aanleren. Benodigdheden in database makkelijk aan te passen aan de studie, ook als die behoeften verschillen per centrum. Data exporteren gaat ook simpel en vlot. Cons: Bij aanvang van onze studie waren er nog geen online handleidingen / instructievideos voor de meeste problemen / functies, maar dat is inmiddels ook opgelost!
Cindy L.
August 25, 2022.
Review Research Manager – Datamanagement module
Pros: Het is een gebruiksvriendelijk pakket met een logische en heldere lay-out. Cons: De helpfunctie mag uitgebreider en het systeem reageert soms nogal traag.
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Compliance, Services & Support
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
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