Cloud-based risk management system for controlling risks to clinical trial quality.
Optimized study design, precise site selection and faster patient recruitment for clinical research - in real time.
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.
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.
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.