Privacy Policy
Who we are
Our main website address is: https://mr-trial-compliance-solver.com
This website is designed to assist fellow MR scientists, Clinical Trial Units (CTUs), and Contract Research Organisations (CROs) in preparing the key documents required for registering research projects within the EU, with EU Competent Authorities, Swissmedic, and local ethics committees.
We have explicitly included CTUs as part of our intended audience, as the CTU I consulted was unable to support these types of Swissmedic/CEC applications. This is largely because such regulatory “paperwork” is typically handled by teams within medical device companies developing new products.
MR researchers who develop their own pulse sequences or use non-CE-marked RF hardware effectively become medical device manufacturers, and are therefore treated by Competent Authorities on the same level as established medical device companies. Determining the applicable regulations alone took me several months; drafting the required documents then demanded the equivalent of seven months of full-time work spread over two years.
Peers, CTUs, and CROs who wish to leverage dedicated GPT tools to produce first drafts of key documents for new MR projects are invited to explore our tailored solutions.
Use of Open-AI (Chat-GPT) tools and document creation
This website may offer tools that use AI language models (such as GPT) to assist with drafting or exploring regulatory content. These tools generate outputs automatically and without human oversight.
In some cases, if you choose a model where I prepare documents for you, I will personally review and refine the generated drafts before sending them to you. These documents will be prepared with the utmost care, but cannot guarantee direct acceptance by Competent Authorities (CAs). In practice, it is common that the first submission requires follow-up or additional clarifications. However, this initial application compels the CA to provide a concrete response that can then be resolved in a second step.
Any outputs (whether automated or reviewed by me) remain for informational support and do not constitute formal regulatory or legal advice. You are always responsible for validating the content and ensuring it meets your local regulatory requirements.
Use of customer-provided documents and NDA protection
If you engage us to prepare regulatory documents (such as a Clinical Investigation Plan or Investigator’s Brochure), we may request technical files from you, like RF coil manufacturer documentation or a scientific description of your project. These materials are used solely to generate the requested outputs. To guarantee confidentiality, we sign a mutual Non-Disclosure Agreement (NDA) with you before handling such data. Your proprietary information will not be shared with third parties and will only be retained as necessary to fulfill our contractual obligations and comply with Swiss accounting or record-keeping laws.
Comments
When visitors leave comments on the site, we collect the data shown in the comments form, along with the visitor’s IP address and browser user agent string to help spam detection.
An anonymized string (hash) created from your email address may be provided to the Gravatar service to check if you are using it. The Gravatar service privacy policy is available at: https://automattic.com/privacy/. After approval of your comment, your profile picture is visible to the public in the context of your comment.
Media
If you upload images to the website, please avoid uploading images with embedded location data (EXIF GPS). Visitors to the website can download and extract any location data from images on the site.
Cookies
If you leave a comment on our site, you may opt-in to saving your name, email address and website in cookies. These are for your convenience so you do not have to fill in your details again when leaving another comment. These cookies will last for one year.
If you visit our login page, we will set a temporary cookie to determine if your browser accepts cookies. This cookie contains no personal data and is discarded when you close your browser.
When you log in, we will also set up several cookies to save your login information and screen display choices. Login cookies last for two days, and screen options cookies last for one year. If you select “Remember Me”, your login will persist for two weeks. If you log out, login cookies will be removed.
If you edit or publish an article, an additional cookie will be saved in your browser. This cookie includes no personal data and simply indicates the post ID of the article you just edited. It expires after one day.
Embedded content from other websites
Articles on this site may include embedded content (such as videos, images, or articles). Embedded content from other websites behaves in the exact same way as if you had visited the other website.
These websites may collect data about you, use cookies, embed additional third-party tracking, and monitor your interaction with that embedded content, including tracking your interaction if you have an account and are logged in to that website.
Contact forms
If you submit a contact form on this website, we collect the data you enter (such as your name, email address, and message) solely to respond to your inquiry. We do not use this information for marketing purposes unless you explicitly opt in.
Consultancy services and invoicing
If you engage us for paid consultancy services, we will collect the necessary information to issue invoices and comply with accounting obligations. This may include your name, contact details, and VAT or billing data. Such records are retained as required by Swiss accounting and legal standards.
How we protect your data
We take reasonable measures to secure the data processed on this site, including technical safeguards and limiting access to personal information. However, no internet transmission or storage system can ever be completely secure.
Data jurisdiction
This website is operated from Switzerland, and any data processing is subject to Swiss data protection laws (FADP). Where applicable, we also comply with the EU GDPR for visitors from the European Economic Area.
Who we share your data with
If you request a password reset, your IP address will be included in the reset email.
How long we retain your data
If you leave a comment, the comment and its metadata are retained indefinitely. This helps us recognize and approve any follow-up comments automatically instead of holding them in a moderation queue.
For users that register on our website (if any), we also store the personal information they provide in their user profile. All users can see, edit, or delete their personal information at any time (except for changing their username). Website administrators can also see and edit that information.
What rights you have over your data
If you have an account on this site, or have left comments, you can request to receive an exported file of the personal data we hold about you, including any data you have provided. You can also request that we erase any personal data we hold about you. This does not include data we are obliged to keep for administrative, legal, or security purposes.
Where your data is sent
Visitor comments may be checked through an automated spam detection service.
Contact us
If you have any questions about this privacy policy or how we handle data, please get in touch:
- Email: info@mr-trial-compliance-solver.eu
- Phone: +41-31-4028494
Last updated: 07/08/2025