Yes, statements of compliance to various regulations, including 21 CFR Part 11, as well as data privacy laws, can be provided upon request.
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 experiences with us, and some statements are provided on this website.
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.
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.
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.
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.
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.
No, there are no limitations. The largest study in Viedoc has over 700 sites and works without any problem.
Viedoc supports export to Excel, ASCII, SAS, PDF, and CDISC ODM.
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.
The responsibility for performing the UAT always lies with the client. We deliver a validated product and provide release certificates for every release, and those can be downloaded from this website.
No, every release of Viedoc is always backwards compatible, so there is no need for clients to validate ongoing studies for new releases.
Yes, Viedoc Designer has a global library that can be used to store and copy templates.
Viedoc Me is a web application that runs on any device with a browser.
Like any web application, Viedoc Me requires an internet connection to operate.
Each subject needs a user account to be able to use Viedoc Me. The account is automatically generated in the eCRF (Viedoc Clinic) when the investigator initiates Viedoc Me for the subject.
Data from Viedoc Me 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.
No, all actions are performed in Viedoc. The user only needs to log in to one system.
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.
Yes, and site-specific levels can be set based on enrollment/number of subjects. You can also keep track of expiration dates.
Yes, you can enroll/randomize the subject and then immediately allocate their kit all within the same system.
Yes, primary and supplementary therapies (as many as needed) can be set up for allocation.
This feature works for large, multinational studies, as well as in-house facilities.
Yes, all products in the Viedoc eClinical suite are fully 21 CFR Part 11 compliant.
Yes, everything in Viedoc eTMF is, of course, audit-trailed giving you the control you need over your trial—all in one suite.
Not at all; in Viedoc, you can create customizable structures to fit the needs of any trial or organization.
Yes.
No. Because Viedoc Reports is fully integrated into the suite, the data is synced automatically every 24 hrs.
In each graph, the user can filter, sort, and zoom into the data to get a better understanding of the data at any time.
No, Viedoc Reports is included with every study.
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.
When adding a new study in Viedoc Admin, you can choose to add a normal Viedoc study or a Viedoc PMS study.
Although Viedoc PMS contains some progress management features, the product can easily be integrated with any commercial progress management system on the market.
No, if you have been certified in Viedoc Designer, no additional training is required.
Viedoc PMS is specifically developed to fulfill the requirements of the Japanese PMS market. There is, however, no restriction to it being used elsewhere.
Yes, any add-on feature can be added to an existing study license. The price for Viedoc Connect depends on the study specification and is calculated in a similar way as the Viedoc license.
Just indicate how many estimated televisits will be required.
No, video calls can be set up instead of visits but also in between. There is no link between an event in the EDC and a video call. The easiest implementation is to add a question in a form in the event to collect the information on whether the event was performed as a physical visit or a video call.
"The system is incredibly robust and is very user friendly, both to sponsor level satff, as well as site staff who remotely enter data."