What is it?How it worksDemoTechnical Specifications
How it works

1. View the Sales Demo

A sales demo video is available on our website. This sales demo will cover a number of areas, including: (a) an explanation for whom docuBridge ONE was designed; (b) a brief run through on how to compile and publish an eCTD using the software; (c) "How it works" - explaining this page in more detail; (d) explain how you will be able to get help once you're started. If you still have questions after watching the sales demo video, please book a Q&A Session and one of our competent staff will assist you further.

2. Apply for a LORENZ ID

If you haven't done so already, apply for a LORENZ ID. We understand that this is yet another registration on another website - but it is important. As you are entering into a pay-per-publish model (explanation will still follow), it is vital we associate your publishing needs with your account, and not that of someone else!

3. Visit our Online Store

Once you have your LORENZ ID and have logged in, you can visit our online store. You can begin adding the necessary items to your cart and proceed to checkout. You will have a number of payment options, including credit cards, Paypal and wire transfer. Once the payment has been cleared (in case of wire transfer this will depend on your banking facilities) you will have access to a new section on your LORENZ ID homepage entitled "ONE".

We do not store any of your credit card details. The entire online payment transaction is handled through our partner, CleverBridge AG.

Please remember: you do not need to purchase anything else but the actual software product (be sure to select the applicable region of docuBridge ONE) to get started! The package already includes a publishing token as well as a live support hour to use once whenever you are stuck! So, please don't give us more money than you need to!

4. Accept the End-User License Agreement

If you see the "ONE" menu item when you are logged into your LORENZ ID homepage and click it, then you will have to accept the End-User License Agreement before you get started. You only need to do this once!

If you do not accept the End-User License Agreement for whatever reason, we will reimburse your purchase.

5. Download & Install the Software

Proceed to download both docuBridge ONE and - if you have not done so already on a previous occasion - the LORENZ eValidator Basic. docuBridge ONE amounts to approximately 12MB and is a "zipped", or compressed, file. Any operating system from Windows XP upwards is able to natively unpack this file. Once you have done so, simply run the SETUP file.

The How to Install docuBridge ONE 2.x Guide will walk you through the installation. The guide can be found on the ONE Training page. The setup will install a database engine automatically if it does not find one it can work with. It will then install docuBridge ONE itself. The entire setup will usually take under 7 minutes, pending performance of your computer.

6. Activate the Software

When you first launch docuBridge ONE you will be asked to activate your software to run on your computer. Simply follow the dialog box which directs you to our website, re-enter your LORENZ ID credentials and you will receive an email with your license file. This is the file that you then locate from the dialog box - once activated, you are ready to go!

7. Assemble your Submission

You can begin creating and assembling a submission. Simply choose the appropriate template(s), and then start dragging and dropping documents into the submission template.

You can also view your submission, hyperlink it as well as make annotations to set yourself reminders of items that still need to be completed. When you view a submission, you will be reminded that the submission has not yet been activated for publishing, but you can ignore that during assembly.

8. Activate your Submission & Publish ("Pay-per-Publish")

When you are ready to publish, or in fact at any time during assembly, you can activate your submission sequence which in turn will add the publishing functionality.

With your first purchase you will also have received a free publishing token. You can use that token to activate your first submission sequence. Much like activating the software, simply follow the link to our website from the dialog box reminding you that the submission needs to be activated, add your LORENZ ID credentials, as well as a reference so you can easily identify for which submission you used the token, and that's it! You will receive an email with your submission license, and much like you did when activating the software, you locate that license from the dialog box and your submission is ready to publish.

Please note: Once a submission sequence is activated, you can publish the submission ANY number of times - once, ten times or even a thousand times if you like! You will only require another publishing token if you are creating a new submission or a new submission sequence. This ensures that you can also "test publish" any number of times to make sure you get it right. This is what we call the "pay-per-publish" business model.

9. Validate your Submission

Please, please, please DO NOT forget to validate your submission with our free eValidator before you send it to the regulatory agency. This is a very important step and will minimize the risk that you receive a refusal-to-file from the regulators on technical grounds.

Please note: Validation in this context means performing a technical validation of your electronic submission according to the current ICH, regional and national guidelines. The eValidator will not check whether you content and science is accurate!

10. Submit to the Agency

Once you are happy with your validation results, follow the national / regional guidelines and send the submission to the regulatory agency. For example, there will be guidelines on which media to send the submission on (e.g., CD or DVD, possibly even uploading to a Gateway via the Internet). There may be additional information on how to label your media, and which information needs to be in the cover letter. Please check your national guidelines for further information.

Please note: Pending on the country you are submitting to, there may be additional information about agency specific submission requirements in the user guides within your ONE Training section.