Viedoc Clinic

  • Is Viedoc CFR part 11 compliant?

    Yes, statements of compliance to various regulations, including 21 CFR Part 11 as well as data privacy laws can be provided upon request.

  • Your system seems easy to use but what is the main differentiator compared to other EDC systems?

    Instead of comparing us with other vendors we let the system speak for itself. Anyone with interest can try out Viedoc free of charge for a limited time by simply sending us an email. We also let our clients share their experience with us and some statements are provided on this website.

  • Does Viedoc store an independent contemporaneous investigator copy of the eCRF?

    Yes, Viedoc stores all versions of a form at the time the form is saved and these are all under the control of the investigator.

  • Where and how often are backups performed?

    Backups are taken, encrypted and replicated to the paired Microsoft Azure region every five minutes. One full backup for each instance is encrypted and transferred to cold storage in a third location, read back, restored and tested for integrity every 24 hours.

Viedoc Admin

  • What kind of support do you provide?

    We provide technical support 24/7. Helpdesk to sites is provided by each client through Viedoc Admin and we support our clients if they have any questions or problems.

  • Who has access to Viedoc Admin?

    Access to Admin is normally restricted to study and site managers but it is up to each organization to manage access the way they prefer.

  • How does your pricing model work?

    Viedoc is provided as a SaaS meaning it is licensed per project. The license fee is based on several factors such as duration of study, number of sites, forms, phase etc. To get a good understanding of the price, please request an offer on this website and we will reply within 24 hours with a price.

  • Is there any limitation in number of sites that can be added?

    No, there are no limitations. The largest study in Viedoc has over 700 sites and works without any problem.

  • What export formats do you support?

    Viedoc supports export to Excel, ASCII, SAS, PDF and CDISC ODM.

Viedoc Designer

  • Do I need any programming skills to set up studies in Viedoc?

    No, programming skills are of course of advantage when it comes to very complex conditions or edit checks but for a typical study no programming skills are required.

  • Who is responsible for the UAT, myself or you?

    The responsibility for performing the UAT always lies on the client. We deliver a validated product and provide release certificates for every release and those can be downloaded from this website.

  • I understand you do releases quite often. Do I need to revalidate my study for every release?

    No, every release of Viedoc is always backwards compatible so there is no need for clients to validate ongoing studies for new releases.

  • Do you have a library that can be used when setting up new studies?

    Yes, Viedoc Designer has a global library that can be used to store and copy templates from.

Viedoc Me

  • Is ViedocMe an app that you have to download or a web application?

    ViedocMe is a web application that runs on any device with a browser.

  • Does ViedocMe operate both online and offline?

    Like any web application ViedocMe requires an internet connection to operate.

  • How is the data submitted from the subject’s phone linked to the subject data in the eCRF?

    Each subject needs a user account to be able to use ViedocMe. The account is automatically generated in the eCRF (Viedoc Clinic) when the investigator initiates ViedocMe for the subject.

  • How is the data generated through ViedocMe stored?

    Data from ViedocMe is stored exactly the same way as the rest of the data for the subject. Same security and control. No data is ever stored locally on the subject’s device.

Viedoc Logistics

  • Do we still need an external IWRS or IVRS?

    No, all actions are performed in Viedoc. The user only needs to login to one system.

  • Do actions happen in the system immediately?

    Yes, you don’t have to wait for system updates at a certain time of day. Kits are available as soon as they are registered as received.

  • Are there alerts for low numbers of kits at a site?

    Yes, and site-specific levels can be set based on enrollment/number of subjects. You can also keep track of expiration dates.

  • Does this work for both Open-Label and Double-Blind studies?

    Yes, you can enroll/randomize the subject and then immediately allocate their kit all within the same system.

  • Can I allocate more than one type of therapy?

    Yes, primary and supplementary therapies (as many as needed) can be set up for allocation.

  • What if I have more than one distribution center?

    This feature works for large, multinational studies, as well as in-house facilities.

Viedoc TMF

  • Is the eTMF feature 21 CFR Part 11 compliant?

    Yes, all products in the Viedoc eClinical suite are fully 21 CFR Part 11 compliant.

  • Is there an audit trail for everything that is done?

    Yes, everything in Viedoc eTMF is, of course, audit-trailed giving you the control you need over your trial — all in one suite.

  • My study is unique will I be limited to the structure provided?

    Not at all; in Viedoc, you can create customizable structures to fit the needs of any trial or organization.

Viedoc Reports

  • Can I compare data across different CRF’s?

    Yes.

  • Do I have to wait for the data to be imported?

    No. Because Viedoc Reports is fully integrated into the suite, the data is synced automatically every 24 hrs.

  • What if I want to look a little closer at the data in the graphs?

    In each graph, the user can filter, sort, and zoom into the data to get a better understanding of the data at any time.

  • Does this require a special license?

    No, Viedoc Reports is included with every study.

  • Can I determine who sees what?

    Yes, Viedoc Reports enables you to set up visibility conditions and user roles, allowing the right people to see the important information at the right time.

Viedoc PMS

  • How do I get access to Viedoc PMS?

    When adding a new study in Viedoc Admin you can choose to add a normal Viedoc study or a Viedoc PMS study.

  • Does Viedoc PMS also include progress management?

    Although Viedoc PMS contains some progress management features, the product can easily be integrated with any commercial progress management system on the market.

  • Is there any additional designer training required to use Viedoc PMS?

    No, if you have been certified in Viedoc Designer no additional training is required.

  • Can Viedoc PMS be used in any PMS study outside of Japan?

    Viedoc PMS is specifically developed to fulfil the requirements on the Japanese PMS market. There is however no restriction to it being used elsewhere.

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