Lysosafe HRA-PHARMA

Terms of use of Lysosafe service.

a. LYSOSAFE Service is a free of charge mitotane plasma level testing service associated with the use of LYSODREN in patients with advanced Adrenal Cortical Carcinoma. LYSOSAFE allows the LYSOSAFE contact to frequently perform mitotane plasma level assays during LYSODREN treatment. Each sample result is validated by the LYSOSAFE assay manager. A specific certified result report is sent to the LYSOSAFE contact by email/fax and regular mail.

b. Access to LYSOSAFE ONLINE will enable the LYSOSAFE contact to have a complete historical overview of the mitotane plasma level results of their patient(s). However, the sample result mentioned on the specific certified result report should be considered as the validated and thus correct result.

c. Each LYSOSAFE contact registered for LYSOSAFE ONLINE will have access to the results of the patient(s) he/she recieves the specific result report for.

Terms of use of data transfer to ENS@T

a. Laboratoire HRA Pharma markets Lysodren, a treatment of adrenocortical carcinoma (ACC).

b. Laboratoire HRA Pharma provides Lysodren prescribers with a free of charge service (Lysosafe) consisting in periodic dosages of mitotane in ACC patients.

c. Anonymous data related to such dosages (the “Data”) consisting in patient code, analysis code, date of sample, date of result, mitotane plasma concentration are entered into a secured database (“Lysosafe Database”) accessible to Lysodren prescribers.

d. Lysodren prescribers are responsible for informing their patients and obtaining their prior consent for use of Lysosafe Database and advise such patients that they have the right to modify personal data by emailing to lysosafe@hra-pharma.com.

e. ENS@T ACC Registry is a security-driven portal which offers the opportunity to register ACC patients with a core dataset.

f. Laboratoire HRA Pharma and ENS@T conduct collaborative endeavors to improve the diagnosis and treatment of ACC.

g. Laboratoire HRA Pharma and ENS@T have decided to provide ENS@T on a regular basis with a preformatted file of Data of ACC patients designated by Lysosafe Database users. ENS@T will use this file in order to update ENS@T ACC Registry.In doing so, Lysosafe Database users acknowledge that:

Back to homepage