Compliance and Security


We prioritize privacy and security, and understand that better clinical research experiences necessitate that regulatory compliance be at the foundation of all development and processes. 

We are compliant to FDA 21 CFR Part 11, HIPAA, EU GDPR, ICH GCP E6 (R2), and GAMP-5, among others. 

Clinical ink partners with our customers early in the protocol development process to select the appropriate and relevant digital tools that will be acceptable to the relevant regulatory agency. We have worked on clinical studies that have been under the purview of global regulatory agencies, including the FDA and EMA. We follow FDA guidelines and GCP standards including the following: • ICH E6 (R2) – Guideline for Good Clinical Practice; December 2016• ICH E8 – General Considerations for Clinical Studies; April 2022• FDA 21CFR11 Guidance –Electronic Records/ Signatures –Scope and Application; August 2003• CDISC Standards to Facilitate Use of Electronic Source; November 2006• FDA Guidance Computerized Systems Used in Clinical Investigations; May 2007• EMA eSource Reflection Paper; June 2010• EMA Qualification Opinion on eSource Direct Data Capture (DDC); July 2019• FDA Compliance Program Guidance Manual (Sponsors, Monitors); March 2011• FDA Guidance on Electronic Source Data in Clinical Investigations; September 2013• FDA Guidance for Industry: Use of Electronic Health Record Data in Clinical Investigations; May 2016• FDA Draft Guidance on DHT for Remote Data Acquisition in Clinical Investigations; December 2021


Summary of our Privacy Practices


The Types of Information Clinical ink Collects About You: We collect information that you provide to us, such as your contact details, as well as information that is automatically collected by our Products, such as your Internet Protocol (“IP”) address and information collected by our use of Cookies.

The Purposes of Processing Your Information: We process information about you to provide our Products and Services; to communicate with you; to comply with law and prevent fraud; and for other reasons with your consent. We may also anonymize your data – which means the data can no longer be used to identify you – to perform analytics to learn how to better provide our Products and Services.

Your Rights and Choices: Depending on your jurisdiction, you may have legal rights associated with our processing of your data, including rights to access, correct, delete, transfer, or object to the processing of your data. Regardless of where you live, we will honor your request to opt out of being contacted by us for marketing reasons.

How to Contact Us: Clinical ink is the controller of your information when it is processed in the context of our Products and Services. Our Data Protection Officer may be contacted by emailing

Please note that Clinical ink’s customers are the controllers of your data when it is processed in the Clinical ink platform, applications, and related services. For example, if you are a patient in a clinical trial, or an investigator who logs into our applications, your data controller is the Sponsor of that trial and/or the participating healthcare provider.

To view the full privacy policy, please go to

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