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Main address: Margarethenstrasse 47 4053 Basel, Switzerland ,
Tel:+41 61 865 60 60 , E-mail: info(at)clinerion.com Website:

Clinerion Quality Risk Management System

Clinerion Quality Risk Management System

Cloud-based risk management system for controlling risks to clinical trial quality.

Clinerion Patient Recruitment System

Clinerion Patient Recruitment System

Optimized study design, precise site selection and faster patient recruitment for clinical research - in real time.



Patient Privacy

Independently Assessed.

Clinerion's Patient Recruitment System has been evaluated by an independent, third party expert* and is confirmed to be fully compliant with data privacy regulations in the USA (HIPAA) and the EU (Directive 95/46/EC).

* NB. The expert’s evaluation is based on the design of the Clinerion PRS tool suite and the practices according to their design, as of July 25, 2016.

Clinerion’s Policy on Patient Privacy.

Bringing forward the best treatment and care for patients by accelerating the development of innovative medicines is at the forefront of everything that Clinerion does.

Clinerion is committed to the principle that patient data belongs to the patient. It is for the patient to decide where and how their health data is stored, distributed and made available. Being committed to the trustworthy re-use of health data for research, Clinerion’s solutions therefore only view data at aggregated level, and access them following already-existing permissions given to the hospitals where the data resides.

The Patient Recruitment System (PRS) was developed following the approach of “Privacy by Design,” and patient privacy in PRS is maintained through procedures and policies ensuring consistency with Good Clinical Practice (GCP), the Health Insurance Portability and Accountability Act (HIPAA) and the EU Data Protection Directive (95/46/EC).

PRS runs inside the secure IT infrastructure of a hospital; all critical processes run inside hospitals’ infrastructures and no identifiable patient data is transferred outside. Patient data is de-identified (pseudonymized) while on hospital-controlled infrastructure. Encryption keys used are exclusively under hospital control.

Components:

  • De-identification: identifiable patient data are removed or pseudonymized within the hospital’s own system before transfer to the PRS server located within the hospital.
  • Aggregation / anonymization: PRS queries only de-identified patient data and, in return, receives fully anonymized results in aggregated form – e.g. count of matching patients for site feasibility evaluation.
  • Re-identification: re-identification of patient data is enabled for recruitment of a patient into a clinical trial, but only within the hospital network and only by the authorized hospital staff.
  • Data protection is enabled by pseudonymization, secure transfer and access control mechanisms.
  • Clinerion ensures that the users to whom it extends information system access understand and treat that access with appropriate regard for information security.
  • All Clinerion personnel are trained in this security framework structure.

Methods for De-identification of Protected Health Information

For the responsible use and disclosure of health data without the need for patient consent, PRS follows the standard methods for Safe Harbor and Expert Determination established by HIPAA.

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