viedoc™ edc & epro · pdf fileedc and epro since 2003 viedoc 4, the latest major...
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Viedoc™EDC & ePRO
Enjoy your trial™
The Proven SolutionEDC and ePRO since 2003
Viedoc 4, the latest major release of Viedoc, changes the way you conduct clinical trials. Whatever your previous experience of EDC might be, Viedoc 4 is something new: smarter, easier and quicker.
Viedoc doesn’t compromise: Viedoc is an EDC system that is both easy to learn and powerful. All features have been carefully thought through and unnecessary steps and processes have been eliminated making it one of the most feature rich yet easy to manage e-clinical suites.
Viedoc is based on extensive EDC experience. It has been widely used all over the globe, in all therapeutic areas and clinical phases since 2003.
Viedoc 4 is based on the most current technology and processes, utilizing the experience we have gained in over 1000 trials in more than 60 countries globally.
VIEDOC SINCE 2003.
64COUNTRIES
14LANGUAGES
12,000SITES
300,000SUBJECTS
THEGIVEN
THINGS
21CFR11 COMPLIANT
SECURE STORAGE OF SUBJECT DATA
DO YOUR OWN STUDY SET-UPSGET STARTED IN HOURS
ACCESS TO DATA 24/7
AUDIT PCG SOLUTIONSYES, AUDIT ON-SITE/REMOTE
TRAINING MODE/LIVE MODE
BROWSER INDEPENDENT
ANY PHASE/COUNTRY/ THERAPEUTIC AREA
HOSTING, TECHNICAL HELPDESK ETC. INCLUDED IN LICENSING
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The Simple SolutionIt's easy to get started
Take the Viedoc web training course on how to perform study set ups, set-up your first study the same day. Sites are easily trained at the initiation visit by the CRA.
How does it work?
Viedoc consists of four modules:
Viedoc Clinic is the interface for the end user, i.e. the site sta�, CRA, Data and Project Manager. In Viedoc Clinic all the day-to-day operations are performed.
Viedoc Admin is the interface where you initiate a new study, manage the study while it’s running and finally close the study.
Viedoc Designer is the tech part where you design forms, set the study workflow, add roles, prepare the randomization, add edit checks and much more.
ViedocMe is the subject diary, or ePRO. All subject questionnaires are easily completed and submitted by the subject through this application.
EASYSET UP IN
HOURS
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Viedoc Clinic keeps track of all the activities performed by the site. The modern, streamlined interface allows you to e�ciently manage and review clinical trial data in less time. The site sta�, investigator / clinical research coordinator / study nurse can at any time manage all site activities:
● Add subjects
● Manage and add subject data
● Randomize
● Answer queries
● Sign data
● Medical coding
● Manage subject diaries in ViedocMe ePRO
● Export data in multiple formats (CSV, Excel, SAS, PDF and CDISC ODM)
● Smart preview of data, in tables or graphs
And much more! Let us know if you have any questions.
The Clinical SolutionViedoc Clinic
The Global Study DEMO
FOR THE INVESTIGATOR
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Viedoc Admin is where you initiate your new study. No need to contact the helpdesk or the data manager to get things done.
In Viedoc Admin you:
● Assign the sta� to the study, e.g. the Viedoc Designer to the CRF,
● Set up the sites and settings (time zones, language etc),
● Add CRA(s) to the sites…
● … and the CRA adds the site sta� to the sites.
● Manage CRF versions, Viedoc can manage di�erent CRF versions at di�erent sites / countries
● Manage your resources by central / risked based monitoring (RBM)
● Everything is of course audit trailed, you have full control over when users have logged in, which version of the CRF is applied to the sites etc.
And much more! Let us know if you have any questions.
The Administrative SolutionViedoc Admin
FOR THE CLINICAL RESEARCH PROFESSIONALS
Demo organization
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DEMO
Viedoc Designer makes it easier than ever to setup and design professional studies. The included ready-to-use industry templates allow you to create professional input fields and questionnaires tailor-made for you. No design or programming skills are required although basic understanding of JavaScript is preferable to get the most out of the system.
Viedoc supports set up of advanced as well as simple studies. New studies are easily set up by using global templates or even entire study designs, all very easy to re-use and add to your study. The simple drag-and-drop functionality to generate new CRF pages allows you to quickly add additional content to your setup.
Create or re-use forms, add logical checks and test them immediately. Viedoc supports use of JavaScript, in which edit checks and functions are programmed. Features include:
● Unlimited forms in a study, drag and drop to create your forms and variables
● Create/manage global library of template studies/forms to be reused any time
● Simple/complex edit checks between variables, forms and visits
● Functions or default values
● Multi-language support, including right-to-left typing
● Viedoc Form Translator™, easy and quick process to translate forms into any language, have multiple languages simultaneously in your study
● Web based subject diary ePRO - ViedocMe
● Randomization, no need for external randomization providers
● Triggered emails
● Print empty or annotated CRFs
● API for external data integrations
● Online user guides and e-learning
The Configurable SolutionViedoc Designer
FOR THE DEVELOPER
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Demostudy DEMO
ViedocMe is a smart app that lets your subjects report data comfortably through their phones, tablets or computers at any time (BYOD – Bring Your Own Device). Setup automatic reminders, notifications or e-mails to make sure you collect the right data within the designated time frame.
ViedocMe is an integrated part of Viedoc, when you set up a form in Viedoc you select if you want to post it to the subject or if it will be part of the regular CRF. This allows you to set up the CRF and the subject questionnaires simultaneously saving time and money. As ViedocMe allows right-to-left typing as well as double-byte characters (for e.g. character based languages such as Japanese, Chinese and Korean) it can be used globally.
And much more! Let us know if you have any questions.
The Personal SolutionViedocMe
FOR THE SUBJECTS
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DEMO
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Viedoc is a Software as a Service (SaaS) solution, or as sometimes called, a cloud solution. This means that you don’t have to worry about platform availability, maintenance and backups. We handle that for you. We also make sure your platform is upgraded to the latest version to support the client devices and software that your end-users have. It also means that you can benefit from new features within the scope of your current license and always stay on top of emerging cyber threats. A web browser is all that’s required to access the full functionality of Viedoc, today and tomorrow.
CDISC standards are central in Viedoc, even on a platform-level. The complete study design, the site setup, the users and their roles and permissions, as well as all clinical data, review activities and audit trail, is natively described and stored using the CDISC ODM structure with the CDISC SDM-XML, and a few of our own, extensions. You can import and export a study design from and to any other compliant metadata-repository. Imports of clinical data using CDISC ODM is also handled close to seamlessly, and exports in this industry standard structure is encouraged for use as the final study archive. CDISC ODM is also the
default structure accepted when submitting clinical data to Viedoc through the API.
Viedoc is served out of geographically separated data centers with real-time data replication. Data security is our top priority. The infrastructure solution is owned, managed and monitored by our own in-house operations team 24/7. All to make sure your data is safe and available at all times. Your data will not leave our domains unless you say so.
Viedoc is compliant with good practices and regulatory requirements for clinical trials issued by authorities such as ICH, FDA, EMA and PMDA. Our vision is to participate where standards are set, to help develop the industry, and at the same time enable it with tools for more e�cient and safe clinical trials. As a company, we are audited roughly every 2nd week, and we welcome any organization to give us a visit.
The Comfortable and Future Proof SolutionSecurity & technology
VIEDOC 4 - EDC & ePRO - ENJOY YOUR TRIAL2015-09-14
ENJOY THE BENEFITSOF A SYSTEM ACCESSIBLE
FROM ANY DEVICE AT ANY TIME.
UPGRADE TO VIEDOC NOW!
www.viedoc.com
Uppsala, [email protected]
Turku, [email protected]
Munich, [email protected]
Tokyo, [email protected]
Shanghai, [email protected]
ENJOY YOUR TRIAL™