The privacy of your personal and medical information is important to us and we are committed to protecting your privacy. This privacy notice applies to participants in a clinical trial sponsored by Akums (Trial) and it provides you with information about our processing of your personal information during and after the Trial.
This privacy notice is supplemental to the participant information sheet and participant consent forms that you have been provided with.
Akums Drugs & Pharmaceuticals Ltd. (Akums, we, our or us) is the controller for the Trial and responsible for your personal information. The clinical trial site processes your personal information on our behalf with regards to the Trial. However, the clinical trial site is still responsible and in control of your personal information (for example, within your medical record) when providing patient care to you and will have independent responsibilities to you in that regard.
Akums has appointed a data protection officer (DPO) who is responsible for overseeing questions in relation to this privacy notice. If you have any questions about this privacy notice, including any requests to exercise your legal rights, please contact the DPO using the information set out below.
We will process different kinds of personal data about you, which we have grouped together as follows:
As mentioned above, we will have access and may further process your full medical record as agreed with the clinical trial site.
We (and service providers that we use) also collect, use and share aggregated data such as statistical or demographic data which is not personal information as it does not directly (or indirectly) reveal your identity.
The clinical trial site collects your personal information as part of your medical care. The patient information sheet will have provided you with information how the clinical trial site works with us.
We have set out below a description of all the ways we plan to use the various types of your personal information, and which of the legal bases we rely on to do so.
| Purpose/Use | Type of Information | Legal Basis |
|---|---|---|
| Conducting the Trial | Identity Data, Contact Data, Health Data and Trial Data. | Legitimate interest and scientific research in the wider public interest |
| Conducting market research and post trial activities | Identity Data, Contact Data, Health Data and Trial Data. | Legitimate interest and scientific research in the wider public interest |
| Use for regulatory approvals (including inspections by regulators) to commercialise our product | Identity Data, Contact Data, Health Data and Trial Data. | Legitimate interest and reasons of public interest in the area of public health |
| Vigilance reporting and incident reporting | Identity Data, Contact Data and Health Data | Compliance with legal obligation and reasons of public interest in the area of public health |
| Use for further research or studies | Identity Data, Contact Data, Health Data and Trial Data. | Legitimate interest and scientific research in the wider public interest |
| Anonymise your data | Identity Data, Contact Data, Health Data and Trial Data. | Legitimate interest and scientific research in the wider public interest |
We require all third parties to respect the security of your personal information and to treat it in accordance with the law.
Please contact us using the contact details above if you want further information on the specific mechanism used by us when transferring your personal information out of the UK.
We have put in place appropriate security measures to prevent your personal information from being accidentally lost, used or accessed in an unauthorised way, altered or disclosed. In addition, we limit access to your personal information to those employees, agents, contractors and other third parties who have a business need to know. They will only process your personal information on our instructions and they are subject to a duty of confidentiality.
We will retain your personal information for as long as reasonably necessary to fulfil the purposes we collected it for, including for legal, regulatory or reporting requirements. We may retain your personal information for a longer period if there is a complaint or a prospect of litigation.
If you have any questions about this privacy notice or want to exercise your privacy rights, please contact us at:
Last updated in September 2025.